Παρασκευή, 1 Φεβρουαρίου 2019

😴😴😴Sleep Medicine🕵🕵️‍♀️


16:51
  Characterizing Pediatric Inpatient Sleep Duration and Disruptions
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Amarachi I. Erondu, Nicola M. Orlov, Leah B. Peirce, Samantha L. Anderson, Michael Chamberlain, Kelsey Hopkins, Christopher Lyttle, David Gozal, Vineet M. Arora

Abstract
Objective
To contextualize inpatient sleep duration and disruptions in a general pediatric hospital ward by comparing in-hospital and at-home sleep durations to recommended guidelines and objectively measure nighttime room entries.

Methods
Caregivers of patients 4 weeks - 18 years of age reported patient sleep duration and disruptions in anonymous surveys. Average at-home and in-hospital sleep durations were compared to National Sleep Foundation recommendations. Objective nighttime traffic was evaluated as the average number of room entries between 11:00pm and 7:00am using GOJO hand-hygiene room entry data.

Results
Among 246 patients, patients slept less in the hospital than at home with newborn and infant cohorts experiencing 7- and 4-hour sleep deficits respectively (Newborn: 787 ± 318 min at home vs. 354 ± 211 min in hospital, p<0.001; Infants: 530 ± 115 min at home vs. 412 ± 152 min in hospital, p<0.01). Newborn children also experienced >2 hour sleep deficits at home when compared to NSF recommendations (Newborns: 787 ± 318 min at home vs. 930 min recommended, p< 0.05). Objective nighttime traffic measures revealed that hospitalized children experienced 10 room entries/night (10 ± 5.9 entries). Nighttime traffic was significantly correlated with caregiver-reported nighttime awakenings (Spearman Rank Correlation Coefficient: 0.58, p=.04).

Conclusion
Hospitalization is a missed opportunity to improve sleep both in the hospital and at home.

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16:51
  Insomnia Treatment Response as a Function of Objectively Measured Sleep Duration
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Amélie Rochefort, Denise C. Jarrin, Lynda Bélanger, Hans Ivers, Charles M. Morin

Abstract
Objectives
To examine the potential moderating effect of objectively measured sleep duration at baseline on the response to cognitive behavioral therapy for insomnia (CBT-I), administered singly or combined with medication (CBT-I+Med).

Methods
Based on the average PSG-derived sleep duration across two baseline nights and the type of treatment received, 159 adults with insomnia (50.3 ± 10.1 years; 61.0% women) were classified into one of four groups: participants with short sleep duration (i.e., ≤ 6h) treated with CBT-I (n = 26) or CBT-I+Med (n = 25), and participants with normal sleep duration (i.e., > 6h) treated with CBT-I (n = 54) or CBT-I+Med (n = 54). Primary outcome measures were sleep/wake parameters derived from a sleep diary and insomnia severity and secondary outcomes were beliefs about sleep, fatigue, depression and anxiety.

Results
Patients with both short and normal sleep durations at baseline improved significantly on most sleep continuity parameters with CBT-I administered singly or combined with medication. Irrespective of treatment received, participants with short sleep duration also showed significantly greater improvements in subjective sleep (i.e., reduced wake after sleep onset, increased sleep efficiency) relative to those with normal sleep duration. Conversely, participants with normal sleep duration showed greater improvements on some measures of daytime functioning and sleep satisfaction.

Conclusions
There was no moderating effect of baseline sleep duration on treatment response to cognitive behavioral therapy. Despite some marginal differential treatment response on selected daytime functioning outcomes, the benefits from CBT-I were not significantly different as a function of short or normal sleep duration at baseline. Further prospective investigation of insomnia phenotypes taking into account other variables than sleep duration is warranted in order to develop more targeted insomnia therapies.

Trial registration
www.clinicaltrials.gov (#NCT 00042146)

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Thu Jan 31, 2019 12:40
  Association of change in physical activity and sleep complaints: Results from a 6-year longitudinal study with Swedish health care workers
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Markus Gerber, Mats Börjesson, Ingibjörg H. Jonsdottir, Magnus Lindwall

Abstract
Objective
To increase our understanding of patterns of change in physical activity and sleep complaints and to test whether intra-individual changes in physical activity are correlated with intra-individual changes in sleep complaints across four measurement time-points over six years, adopting both a between-person and within-person perspective.

Methods
Data from a longitudinal cohort study were used in this research. At baseline, 3187 participants took part in the study (86% women, Mage=46.9 years). The response rate was 84% (n=3136) after two years, 60% (n=2232) after four years, and 40% (n=1498) after six years. Physical activity was assessed with the [51] widely used 4-level physical activity scale (SGPALS), and sleep complaints, with three items from the Karolinska Sleep Questionnaire (KSQ). Patterns and correlations of change between physical activity and sleep complaints were examined with latent growth curve modeling.

Results
Changes in physical activity were associated with changes in sleep complaints across the six years. More specifically, significant associations occurred between baseline levels, correlated (between-person) change, and coupled (within-person change). These associations indicate that higher physical activity levels are not only cross-sectionally linked with fewer sleep complaints, but that increases in physical activity over time (either in comparison to others or to oneself) are paralleled by decreases in sleep complaints.

Conclusions
Given that changes in physical activity and sleep are correlated, our findings indicate that it is both worthwhile to initiate more physically active lifestyles in physically inactive individuals and to ensure that those who are already physically active maintain their physical activity levels over longer periods.

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  Continuous positive airway pressure alters brain microstructure and perfusion patterns in patients with obstructive sleep apnea
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Hillel S. Maresky, Isaac Shpirer, Miriam M. Klar, Max Levitt, Efrat Sasson, Sigal Tal

Abstract
Objectives
To assess the effects of continuous positive airway pressure (CPAP) treatment on brain structure and function in patients with obstructive sleep apnea (OSA).

Methods
A prospective study of seven OSA patients recruited from the sleep center at our institution was carried out. Patients were treated with 6 weeks of CPAP treatment. Pre-treatment and post-treatment magnetic resonance imaging (MRI) perfusion scans were obtained and compared to assess for treatment-induced changes. Microstructural changes were quantified using functional anistrophy (FA) and mean diffusivity (MD), and brain perfusion was quantified using cerebral blood flow (CBF) and cerebral blood volume (CBV).

Results
Of the seven patients included the in study, six (85.7%) were male, and the mean age of the study population was 51 years (standard deviation = 13.14). Increased FA and decreased MD were found in the hippocampus, temporal lobes, fusiform gyrus, and occipital lobes. Decreased FA and increased MD were found in frontal regions for all patients (p<0.05). Increased CBF and CBV were also observed following treatment (p<0.05).

Conclusion
In addition to symptom resolution, CPAP treatment may allow for healing of OSA-induced brain damage as seen by restoration of brain structure and perfusion.

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Thu Jan 31, 2019 12:40
  Postpartum fatigue, daytime sleepiness, and psychomotor vigilance are modifiable through a brief residential early parenting program
via Sleep Medicine
Publication date: Available online 31 January 2019

Source: Sleep Medicine

Author(s): Nathan Wilson, Karen Wynter, Clare Anderson, Shantha.M.W. Rajaratnam, Jane Fisher, Bei Bei

Abstract
Objective
/Background: In the months after childbirth, women are vulnerable to sleep disturbances and sleep-related deficits in functioning, such as fatigue, daytime sleepiness, and attentional lapses. Currently there is limited evidence that these deficits are modifiable. Using both self-report and objective measures, this study examined changes in sleep-related daytime functioning among women attending a residential early parenting program for assistance with unsettled infant behavior and mild to moderate postpartum distress.

Methods
Participants were 78 women (age M=34.16, SD=4.16 years) attending a 5-day program with their infants (age M=8.67, SD=4.82 months). Sleep was assessed via self-report. Sleep-related daytime functioning was operationalized as fatigue, sleepiness, and sustained attention, and measured using validated questionnaires (all women) and the 10-min visual Psychomotor Vigilance Test (PVT; subgroup of 47 women). All measures were administered on both admission (baseline) and discharge.

Results
On admission, participants reported elevated sleep disturbance (94%), fatigue (91%), as well as trait (54%) and state (67%) sleepiness. From admission to discharge, there were medium effect size reductions in fatigue and sleepiness, and large effect size improvements in sleep quality related domains such as increased sleep efficiency and reduced nighttime awakenings (all p<.001); changes in total sleep time were nonsignificant (p=.22). PVT reciprocal mean reaction times were also significantly faster (p=.001; medium effect size).

Conclusions
This study demonstrated that among women attending a brief residential early parenting program, fatigue, daytime sleepiness, and objectively measured psychomotor vigilance can be improved. Implications for further research and potential treatments are discussed.

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Thu Jan 31, 2019 12:40
  Poor sleep quality and lipid profile in a rural cohort (The Baependi Heart Study)
via Sleep Medicine
Publication date: Available online 30 January 2019

Source: Sleep Medicine

Author(s): Glaucylara Reis Geovanini, Geraldo Lorenzi-Filho, Lilian K. de Paula, Camila Maciel Oliveira, Rafael de Oliveira Alvim, Felipe Beijamini, André Brooking Negrão, Malcolm von Schantz, Kristen L. Knutson, José Eduardo Krieger, Alexandre Costa Pereira

Abstract
Aim
To test the association between cardiometabolic risk factors and subjective sleep quality assessed by the Pittsburgh sleep quality index (PSQI), independent of obstructive sleep apnea (OSA) and sleep duration.

Methods
A total of 573 participants from the Baependi Heart Study, a rural cohort from Brazil, completed sleep questionnaires and underwent polygraphy for OSA evaluation. Multivariable linear regression analysis tested the association between cardiovascular risk factors (outcome variables) and sleep quality measured by PSQI, adjusting for OSA and other potential confounders (age, sex, race, salary/wage, education, marital status, alcohol intake, obesity, smoking, hypertension, and sleep duration).

Results
The sample mean age was 43±16 years, 66% were female, and mean body mass index (BMI) was 26±5 kg/m2. Only 20% were classified as obese (BMI ≥30). Fifty per cent of participants reported poor sleep quality as defined by a PSQI score ≥5. A high PSQI score was significantly associated with higher very-low-density lipoprotein (VLDL) cholesterol levels (beta=0.392, p=0.012) and higher triglyceride levels (beta=0.017, p=0.006), even after adjustments, including the apnea–hypopnea index. Further adjustments accounting for marital status, alcohol intake, and medication use did not change these findings. No significant association was observed between PSQI scores and glucose or blood pressure. According to PSQI components, sleep disturbances (beta=1.976, p=0.027), sleep medication use (beta=1.121, p=0.019), and daytime dysfunction (beta=1.290, p=0.024) were significantly associated with higher VLDL serum levels. Only the daytime dysfunction domain of the PSQI components was significantly associated with higher triglyceride levels (beta=0.066, p=0.004).

Conclusion
Poorer lipid profile was independently associated with poor sleep quality, assessed by the PSQI questionnaire, regardless of a normal sleep duration and accounting for OSA and socio-economic status.

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Thu Jan 31, 2019 12:40
  The journal on a new trajectory
via Sleep Medicine
Publication date: January 2019

Source: Sleep Medicine, Volume 53

Author(s): Sudhansu Chokroverty

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🤓🧘 Dangerous non-food products🧛‍♂️🤦🤦‍♀️

Serious risk 

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Alert number: A12/0189/19       
Category:  Hobby/sports equipment
 
Product:  Self-balancing scooter (hoverboard)
 
Brand: GOCLEVER
 
Name: City Board SUV - Hoverboard
 
Type / number of model:  CBLSSBEU Black with LG battery
 
Batch number / Barcode:  5906736072463
 
Risk type:  Burns, Fire
 
The hoverboard's charging circuit has no cut-off switch. The battery can consequently overcharge and overheat which could lead to a fire.
In addition, the plastic housing of the hoverboard can easily catch fire.

The product does not comply with the requirements of the Machinery Directive and the relevant European Standards EN 60335-1 and EN 62133-2.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0190/19       
Category:  Hobby/sports equipment
 
Product:  Self-balancing scooter/Hoverboard
 
Brand: Denver
 
Name: Balance scooter
 
Type / number of model:  Scooter: DBO-6501 WHITE MK2 Power charger: JY-420150
 
Batch number / Barcode:  5706751035494
 
Risk type:  Burns, Fire
 
The charging circuit of the product has no cut-off switch.
The battery can consequently overcharge and overheat which may lead to a fire. Furthermore, the plastic housing of the hoverboard can easily catch fire. 

The product does not comply with the requirements of the Machinery Directive and the relevant European Standard EN 60335-1.
 

Measures ordered by public authorities (to: Other): Warning consumers of the risks, Withdrawal of the product from the market

 

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Alert number: A12/0172/19       
Category:  Chemical products
 
Product:  Tattoo ink
 
Brand: Eternal Ink
 
Name: ROSA - HOT PINK
 
Type / number of model:  Unknown
 
Batch number / Barcode:  Batch number 02/09/16
 
Risk type:  Chemical
 
The product contains the aromatic amine o-anisidine (measured value: 26 mg/kg).
This aromatic amine can cause cancer, cell mutations and affect reproduction. 

The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, recommends that aromatic amines with carcinogenic mutagenic, reprotoxic or sensitising properties should neither be present in tattoos and permanent make-up products nor released from azo-colourants.
 

Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures

 

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Alert number: A12/0174/19       
Category:  Chemical products
 
Product:  Tattoo ink
 
Brand: Eternal Ink
 
Name: CARAMEL
 
Type / number of model:  Unknown
 
Batch number / Barcode:  batch R-136, expiry date 06/2020
 
Risk type:  Chemical
 
The product contains the aromatic amines o-anisidine (measured value 74 mg/kg) and o-toluidine (measured value 67 mg/kg).
Aromatic amines can cause cancer, cell mutations and affect reproduction. 

The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, recommends that aromatic amines with carcinogenic, mutagenic, reprotoxic or sensitising properties should neither be present in tattoos and permanent make-up products nor released from azo-colourants.
 

Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures

 

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Alert number: A12/0179/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Butane gas lighters - coke bottle
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
THE PRODUCT IS COUNTERFEIT
 
Risk type:  Burns, Fire
 
The lighter is appealing to children due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0180/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Refillable butane gas lighter in the form of a lip
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Fire
 
The lighter is appealing to children. due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0181/19       
Category:  Lighters
 
Product:  Novelty lighter
 
Brand: Unknown
 
Name: Accessories - butane gas lighter-fire-extinguisher
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Fire
 
The lighter is appealing to children due to its shape and colour.
Children may play with it and suffer burns or cause a fire. 

The product does not comply with the relevant European standard EN 13869.
 

Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, Withdrawal of the product from the market (By: Other)

 

Alert number: A12/0158/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Cadillac
 
Name: Escalade
 
Type / number of model:  Type-approval number: e13*2007/46*1479*00 Type: K2XX
 
Batch number / Barcode:  The vehicles concerned were manufactured in 2015.
 
Risk type:  Injuries
 
The software is faulty which may lead to sporadic failure of the electric power steering.
The driver might consequently lose control of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0159/19       
Category:  Motor vehicles
 
Product:  Motorcycle
 
Brand: Yamaha
 
Name: Tricity, MWS125, MWS125A, MWS150A
 
Type / number of model:  Type-approval number: e13*168/2013*00049 Type: SEC 2
 
Batch number / Barcode:  The vehicles concerned were produced between 2017 and 2018.
 
Risk type:  Injuries
 
Poor material resistance of the hoses in the area of the cooling water expansion tank can lead to the loss of cooling water.
The cooling liquid could leak onto the road and the rider could consequently lose control of the motorcycle. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0160/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: VW
 
Name: Touareg
 
Type / number of model:  Type-approval number: e1*2007/46*1827*; Type: CR
 
Batch number / Barcode:  The vehicles in question were produced between 8/8/2018 and 5/10/2018.
 
Risk type:  Injuries
 
A seat-belt latch may not have been sufficiently secured to the rear, right-hand seat.
In the event of an accident, the rear seat-belt latch may therefore break, increasing the risk of injuries to passengers.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0161/19       
Category:  Motor vehicles
 
Product:  Passenger Car
 
Brand: Bentley
 
Name: Mulsanne
 
Type / number of model:  Type approval numbers: e11*KS07/46*0116*00, e11*KS07/46*0116*01, e11*KS07/46*0116*02, e11*KS07/46*0116*03, e11*KS07/46*0116*04, e11*KS07/46*0116*05
 
Batch number / Barcode:  The affected vehicles were manufactured between 08/03/2012 and 21/07/2018
 
Risk type:  Injuries
 
The body mounting panels of the rear seatbelt buckle anchorages have been made using an incorrect grade of material.
In the event of an impact accident, if the rear centre seat is occupied at the same time as an outer rear seat, the rear seatbelt buckle may become detached from the bodywork, leading to injuries.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0162/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: A-class
 
Type / number of model:  Type-approval number: e1*2007/46*1829*03; Type: F2A
 
Batch number / Barcode:  The vehicles in question were manufactured between 13/11/2017 and 22/08/2018.
 
Risk type:  Injuries
 
No perforation has been made in the outer covering of the instrument panel to enable the deployment of the passenger airbag.
In the event of an accident involving deployment of the airbag at low temperatures, sharp edges could be created on the instrument panel in the airbag's deployment area, damaging the airbag. Moreover, parts of the instrument panel may become detached, increasing the risk of injury to the occupants. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0163/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: C-class, GLC
 
Type / number of model:  EC type approvals: e1*2001/116*0480*23-30, e1*2007/46*1884*00, e1*2001/116*0431*48-50, e1*2001/116*0457*35-41, e1*2001/116*0463*20, e1*2001/116*0464*22 Types: 204, -X, -X AMG, -K, -K AMG, -AMG
 
Batch number / Barcode:  The vehicles in question were manufactured between 1 August 2017 and 11 October 2018.
 
Risk type:  Injuries
 
In vehicles with automatic child-seat detection, the status shown in the centre console of the passenger airbags may not be correctly indicated.
In this case, the vehicle users would not be correctly informed of the actual activation status of the passenger airbag and may not react appropriately to a potentially false passenger classification, thereby increasing the risk of injury for passengers in the event of an accident. 
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0164/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Mercedes-Benz
 
Name: C-class, E-class, CLS
 
Type / number of model:  EC type-approvals: e1*2001/116*0431, e1*2001/116*0457, e1*2001/116*0501, e1*2007/46*1560, e1*2007/46*1818, e1*2001/116*0464, e1*2001/116*0463, e1*2007/46*1666*08 , Types: 204, 204 K, 212, R1ES, R1ECLS, 204 AMG, 204 K AMG, R1EC
 
Batch number / Barcode:  The vehicles in question were produced between 14 February 2014 and 16 December 2018.
 
Risk type:  Injuries
 
There may be cracks in a securing nut in the steering gear of rear-wheel-drive vehicles.
The nut could consequently break if the steering system is subject to a very high lateral force, which could result in rotating parts in the steering gear affecting the casing and thereby blocking the steering system.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0170/19       
Category:  Motor vehicles
 
Product:  Tyres
 
Brand: Continental
 
Name: Winter Contact TS860
 
Type / number of model:  ECE type approvals: R30: E4 0289778; R117: E4 027400 S2WR2
 
Batch number / Barcode:  This concerns one week of the manufacturing year 2018 identified by the following code: DOT 6GAED29W4118.
 
Risk type:  Injuries
 
Loosening of the tread could occur.
This could have an adverse effect on the handling and stability of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0171/19       
Category:  Motor vehicles
 
Product:  Tyres
 
Brand: Uniroyal
 
Name: MS Plus 77
 
Type / number of model:  ECE type approvals: R30: E4 0268280; R117: E4 025045 S2WR2
 
Batch number / Barcode:  This concerns one week of the manufacturing year 2018 identified by the following code: DOT 6GXWDDBR4118.
 
Risk type:  Injuries
 
Loosening of the tread could occur.
This could have an adverse effect on the handling and stability of the vehicle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0175/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Jeep
 
Name: Cherokee, Compass
 
Type / number of model:  EC type-approvals: e4*2007/46*0783*11, e11*2007/46*4037*02; Types: KL, MX
 
Batch number / Barcode:  The vehicles concerned were produced between 17 March 2018 and 21 June 2018.
 
Risk type:  Injuries
 
Incorrect coating of the brake pistons can result in the formation of gas in the hydraulic system.
This may adversely affect the functioning of the brakes on the rear-axle wheels.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0176/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Alfa Romeo
 
Name: Stelvio
 
Type / number of model:  EC type-approval: e3*2007/46*0435*02; Type: 949; sales description: Stelvio
 
Batch number / Barcode:  The vehicles concerned were produced between 18 January 2017 and 18 September 2018.
 
Risk type:  Fire
 
A non-compliant generator cable may be damaged as a result of contact with the exhaust gas recirculation line.
This could cause a short-circuit and in the worst case fire in the engine compartment.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0178/19       
Category:  Motor vehicles
 
Product:  Vehicle component
 
Brand: JOST
 
Name: KLK HE 1200-22; KLK HE 1300-22
 
Type / number of model:  Unknown
 
Batch number / Barcode:  Period of manufacture: December 2016 to 16.11.2018.
 
Risk type:  Injuries
 
Owing to a defect in the continuous steel casting process, the ball-bearing turntables may break.
Consequently, the connection to the lower turntable of a trailer may be lost, which could lead to an accident.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

Company recall page:  https://www.jost-klk.com/en/

 

Alert number: A12/0183/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Opel
 
Name: Zafira
 
Type / number of model:  Type-approval numbers: e1*2001/116*0325*00-11, e1*2007/46*0497*00-05 Type: A-H/monocab
 
Batch number / Barcode:  The vehicles concerned were manufactured between 2 November 2004 and 24 October 2014.
 
Risk type:  Fire
 
There is a defective regulator on the blower motor.
This can cause a fire in the cable set.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0185/19       
Category:  Motor vehicles
 
Product:  Passenger Car
 
Brand: Land Rover
 
Name: Range Rover, Sport, Velar, Discovery
 
Type / number of model:  Range Rover E11*2007/46*0649 Range Rover Sport E11*2007/46*0909 Range Rover Velar E11*2007/46*3954 Discovery E11*2007/46*3784
 
Batch number / Barcode:  Specific vehicles built between 10/10/2018 and 19/12/2018
 
Risk type:  Injuries
 
The crankshaft pulley retaining bolt may fracture.
As a consequence, the crankshaft nose could break leading to engine power loss and the potential for engine failure. Furthermore, the loose pulley could damage under bonnet components or puncture the bonnet and become a hazard to pedestrians or other road users.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0188/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Porsche
 
Name: 991 Carrera, Cayenne, Macan, Panamera
 
Type / number of model:  Type-approval numbers: se13*2007/46*1187 e13*2007/46*1085* e13*2007/46*1106* e13*2007/46*1107* e13*2007/46*1108* e13*2007/46*1164* e13*2007/46*0970* e13*2007/46*1143* e13*2007/46*1160* , e13*2007/46*1161*; types: 991, 92A, 95B, 970;
 
Batch number / Barcode:  The vehicles concerned were produced in 2014 and 2015
 
Risk type:  Injuries
 
It is possible that the vehicles do not meet the series standards applicable at the time of delivery as regards certain safety systems and assemblies (e.g. seating, front axle control arm bolts, brake components).
As a consequence, the cars might be unsafe.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0192/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Jaguar
 
Name: F-Pace, F-Type, XJ
 
Type / number of model:  F-PACE E11*2007/46*3324 F-TYPE E11*2001/116*0272 XJ E11*2007/46*0089
 
Batch number / Barcode:  Specific vehicles built between 12/10/2018 and 11/12/2018
 
Risk type:  Injuries
 
The crankshaft pulley retaining bolt may fracture.
As a consequence, the crankshaft nose could break leading to engine power loss and the potential for engine failure. Furthermore, the loose pulley could damage under bonnet components or puncture the bonnet and become a hazard to pedestrians or other road users.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0193/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Land Rover
 
Name: Range Rover, Range Rover Sport
 
Type / number of model:  Type Approval Number : Range Rover E11*2007/46*0649 Range Rover Sport E11*2007/46*0909
 
Batch number / Barcode:  Specific vehicles built between 10/11/2017 and 18/12/2018 and fitted with the 4.4L SDV8 diesel engines
 
Risk type:  Injuries
 
Due to a faulty software, the directional indicators may fail to operate when the steering column mounted control stalks are used and the driver does not receive visual or audible warnings if this occurs.
As a consequence, there is an increased risk of a crash.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0194/19       
Category:  Motor vehicles
 
Product:  Passenger car
 
Brand: Bentley
 
Name: Continental GT
 
Type / number of model:  Type approval numbers: e13*2007/46*0634*01 e13*2007/46*0634*02
 
Batch number / Barcode:  Specific vehicles built between 22/01/2018 and 17/12/2018
 
Risk type:  Injuries
 
Due to a software fault a temporary loss of power assistance could occur, requiring the driver to apply additional steering force.
This could lead to an accident.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

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Alert number: A12/0157/19       
Category:  Other
 
Product:  Smart watch for children
 
Brand: ENOX
 
Name: Safe-KID-One
 
Type / number of model:  Unknown
 
Batch number / Barcode:  4260088660947
 
Risk type:  Other
 
The mobile application accompanying the watch has unencrypted communications with its backend server and the server enables unauthenticated access to data. As a consequence, the data such as location history, phone numbers, serial number can easily be retrieved and changed.
A malicious user can send commands to any watch making it call another number of his choosing, can communicate with the child wearing the device or locate the child through GPS. 

The product does not comply with the Radio Equipment Directive.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users

 

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Alert number: A12/0152/19       
Category:  Toys
 
Product:  Toy scooter
 
Brand: illumination
 
Name: Despicable Me DM3
 
Type / number of model:  808580
 
Batch number / Barcode: Unknown
 
Risk type:  Injuries
 
The scooter is not sufficiently stable.
Children can fall to the ground and hurt themselves. 

The product does not comply with the requirements of the Toy Safety Directive and with the relevant European Standard EN 71-1.
 

Measures taken by economic operators: Destruction of the product (By: Importer)
Measures ordered by public authorities (to: Importer): Import rejected at border

 

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Alert number: A12/0168/19       
Category:  Toys
 
Product:  Children's fancy-dress costume
 
Brand: Unknown
 
Name: ABYED - Anime Animal Costume Cosplay
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Choking
 
The slider of the zip can be easily detached.
A child could put it in the mouth and choke on it. 

The product does not comply with the requirements of the Toy Safety Directive and the relevant European Standard EN 71-1.
 

Measures taken by economic operators: This product listing was removed by AMAZON, Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0182/19       
Category:  Toys
 
Product:  Pull-along toy
 
Brand: ECOTOYS
 
Name: Drewniany piesek na sznurku
 
Type / number of model:  Item N0. 2205
 
Batch number / Barcode:  4 894063 031592 Seria 07/2016
 
Risk type:  Strangulation
 
The cord attached to the toy is too long.
The cord could wrap itself around the child's neck without the child being able to remove it, causing strangulation.

The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-1.
 

Measures ordered by public authorities (to: Importer): Making the marketing of the product subject to prior conditions

 

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Alert number: A12/0184/19       
Category:  Toys
 
Product:  Educational toy
 
Brand: Makeblock
 
Name: mBot
 
Type / number of model:  FRA mBot V1.1-Blue (bluethooth version)
 
Batch number / Barcode: Unknown
 
Risk type:  Burns, Chemical
 
Due to a short-circuit, the batteries can overheat and the plastic of the battery compartment can melt. Moreover, the battery compartment of the remote-control can easily be opened without use of any tools, giving access to the button cell batteries.
A child may sustain burns from the overheating parts or put the batteries in the mouth and swallow them, which can cause damage to the child's gastrointestinal tract. 

The product does not comply with the requirements of the Toy Safety Directive and the relevant European standards EN 62115 and EN 71-1.
 

Measures ordered by public authorities (to: Importer): Import rejected at border

 

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Alert number: A12/0191/19       
Category:  Toys
 
Product:  Squeezable toy
 
Brand: Unknown
 
Name: Children's toy
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Chemical
 
The plastic material of the product contains di-(2-ethylhexyl) phthalate (DEHP) (measured value: 12% by weight) and diisobutyl phthalate (DIBP) (26% by weight).
These phthalates may harm the health of children causing possible damage to the reproductive system.

The product does not comply with the REACH Regulation.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0195/19       
Category:  Toys
 
Product:  Soft toy
 
Brand: Unknown
 
Name: Soft toy turtle, 18 cm
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Chemical, Choking
 
The eyes and the suction cup can easily be detached and the paint on the eyes contains lead (measured value: 63 mg/kg)
The fibrous stuffing material of the toy is easily accessible due to the weakness of certain seams.

A small child may put the small parts, the suction cup or the stuffing material in the mouth and choke. Exposure to lead is harmful for human health and can cause developmental neurotoxicity.

The product does not comply with the requirements of the Toy Safety Directive and with the relevant European standards EN 71-1 and EN 71-3.
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Other)

 

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Alert number: A12/0196/19       
Category:  Toys
 
Product:  Electric toy
 
Brand: Unknown
 
Name: Funny microphone
 
Type / number of model:  NO. 729
 
Batch number / Barcode: Unknown
 
Risk type:  Environment
 
Four solders in the toy contain lead (measured value up to 44.8% by weight) and two of the four solders contain cadmium (measured value up to 0.66% by weight) in concentrations above limit values.

Lead and cadmium pose a risk to the environment.
The product does not comply with the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive). 
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Importer)

 

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Alert number: A12/0200/19       
Category:  Toys
 
Product:  Science kit
 
Brand: Alga
 
Name: Electro Alarm
 
Type / number of model:  21928505
 
Batch number / Barcode:  4893669285057
 
Risk type:  Environment
 
Solder in one place in the toy contains lead in concentration above limit value (measured value up to 11.7% by weight).
Lead poses a risk to the environment. 

The product does not comply with the Commission Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive).
 

Measures taken by economic operators: Withdrawal of the product from the market (By: Manufacturer)

 

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Alert number: A12/0165/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's dress
 
Brand: Lamond
 
Name: Lány ruha
 
Type / number of model:  999-0521-3
 
Batch number / Barcode: Unknown
 
Risk type:  Choking, Injuries
 
The small decorative rhinestones can easily be detached from the dress. 

A small child may put them in the mouth and choke.
The sharp safety pin of the decorative flower is easily accessible.

A small child may put the small parts in the mouth and choke, while the safety pin can cause eye or skin injuries.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market

 

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Alert number: A12/0166/19       
Category:  Clothing, textiles and fashion items
 
Product:  Babies' clothing set
 
Brand: Petite Ponpon Baby
 
Name: Unknown
 
Type / number of model:  Unknown
 
Batch number / Barcode: Unknown
 
Risk type:  Choking
 
The small decorative elements of the product may be easily detached.
A small child may put them in the mouth and choke.
 

Measures ordered by public authorities (to: Distributor): Recall of the product from end users, Withdrawal of the product from the market

 

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Alert number: A12/0169/19       
Category:  Clothing, textiles and fashion items
 
Product:  Ladies' sandals
 
Brand: ElleNor
 
Name: Damen Pantolette
 
Type / number of model:  Unknown
 
Batch number / Barcode:  4039653754509
 
Risk type:  Chemical
 
The amount of chromium (VI) in the leather of the insoles is too high (measured value 12.4 mg/kg).
Chromium (VI) is sensitising and may trigger allergic reactions.

The product does not comply with the REACH Regulation.
 

Measures taken by economic operators: Recall of the product from end users (By: Importer)

 

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Alert number: A12/0186/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's sweatshirt
 
Brand: RITCHIE JEANS CO
 
Name: Deška jopa
 
Type / number of model:  RT7394X, Reference: WIPACK J
 
Batch number / Barcode:  3660283413408
 
Risk type:  Strangulation
 
There are drawstrings with free ends in the hood.
The drawstrings may become trapped during various activities of the child, leading to strangulation.

The product does not comply with the relevant European standard EN 14682.
 

Measures taken by economic operators: Making the marketing of the product subject to prior conditions (By: Distributor)

 

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Alert number: A12/0187/19       
Category:  Clothing, textiles and fashion items
 
Product:  Children's sweatshirt
 
Brand: LONGBOARD
 
Name: Deška jopa
 
Type / number of model:  JUST MUVE, Reference 46974000
 
Batch number / Barcode:  3253538179817
 
Risk type:  Strangulation
 
There are drawstrings with free ends in the hood.
The drawstrings may become trapped during various activities of the child, leading to strangulation.

The product does not comply with the relevant European standard EN 14682.
 

Measures taken by economic operators: Making the marketing of the product subject to prior conditions (By: Distributor)

 

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Alert number: A12/0173/19       
Category:  Cosmetics
 
Product:  Hair dye
 
Brand: Color Mate
 
Name: Hair Color
 
Type / number of model:  Light Brown 9.7
 
Batch number / Barcode:  8 906016 050843 Batch Number: 07
 
Risk type:  Chemical
 
The product contains barium (measured value: 13.6 % by weight) as peroxide.

Barium peroxide is corrosive and irritant. Barium can be absorbed from the dye and have toxic effects on kidney and heart.
The product contains too much p-aminophenol (measured value: 13.6% by weight, final calculated concentration: 3.8%) and insufficient coupling agent.

Uncoupled p-aminopohenol is a strong skin sensitiser and may trigger allergic skin reactions.

The product does not comply with the Cosmetic Products Regulation.
 

Measures ordered by public authorities (to: Retailer): Destruction of the product

 

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Alert number: A12/0153/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Samsung (Counterfeit)
 
Name: Samsung EP-TA20EWE (Counterfeit)
 
Type / number of model:  EP-TA20EWE
 
Batch number / Barcode: Unknown
THE PRODUCT IS COUNTERFEIT
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0154/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: EP-TA20EWE
 
Type / number of model:  EP-TA20EWE
 
Batch number / Barcode:  86696806738
 
Risk type:  Electric shock
 
The electrical insulation and the clearance /creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

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Alert number: A12/0155/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: Unknown
 
Type / number of model:  keke-f5
 
Batch number / Barcode: Unknown
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 

1 of 2 photos

Alert number: A12/0156/19       
Category:  Electrical appliances and equipment
 
Product:  USB-Charger
 
Brand: Unknown
 
Name: Unknown
 
Type / number of model:  EP-TA20JWE
 
Batch number / Barcode:  S/N R37G15Z7JP1RT3
 
Risk type:  Electric shock
 
The electrical insulation and the clearance/creepage distances between the primary and accessible secondary circuit are not sufficient.

The user could touch accessible live parts and receive an electric shock.

The product does not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60950.
 

Measures ordered by public authorities (to: Other): Withdrawal of the product from the market

 
Weekly overview report on professional products
Serious risk 

Alert number: A12/0167/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mitsubishi Fuso
 
Name: eCanter
 
Type / number of model:  Type-approval number: E4*2007/46*0785*; Type: FE4P10TF1N2
 
Batch number / Barcode:  The vehicles concerned were produced between September 2017 and December 2017.
 
Risk type:  Burns, Fire, Injuries
 
Owing to a defective power distribution unit (PDU), short circuits in the vehicle electronics may occur. Increased resistance or a power interruption may occur and/or, where currents are high, a thermal event may ensue.
This could lead to the vehicle breaking down or catching fire.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0177/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mercedes-Benz
 
Name: Econic
 
Type / number of model:  Type-approval number: e1*2007/46*1221* Type: NGE-L64
 
Batch number / Barcode:  The vehicles in question were manufactured between 1 October 2013 and 26 July 2018.
 
Risk type:  Injuries
 
Pneumatic brake lines on the parking brake may, under certain conditions, be damaged by chafing on the drive shafts when the vehicle is lowered to the lowest position.
As a result, it could, over time, cause the wheels to jam when applying the brakes.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0197/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Mercedes-Benz
 
Name: Unimog
 
Type / number of model:  Type-approval numbers: e1*2007/46*1214, *1215, *1216 Types: UGE-452, UGE-232, UGE-453
 
Batch number / Barcode:  The vehicles affected were produced between August 2013 and January 2018.
 
Risk type:  Injuries
 
There is a possible damage to the electrical wiring harness.
This may affect the functioning of the rear lighting unit (including trailer), the electrical supply to the cab, the motor control module (MCM) and the anti-lock braking system (ABS) of the rear axle.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0198/19       
Category:  Motor vehicles
 
Product:  Lorry
 
Brand: Scania
 
Name: 4-, G-, P-, R-series and possibly others
 
Type / number of model:  EC type-approvals: e4*2007/46*0030, *0031, *0032, *0038, *0039, *0040, *0045, *0046, *0605 and possibly other types: N320, N321, N322, N330, N331, N332, N340, N341, N351.
 
Batch number / Barcode:  The vehicles affected were produced between 2007 and June 2017.
 
Risk type:  Injuries
 
Defective alignment of the steering geometry, or inadequate alignment of the steering stops, may result in chafing of the wheels on the steering column.
As a result, the steering column might break, leading to a loss of steering control.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

Alert number: A12/0199/19       
Category:  Motor vehicles
 
Product:  Bus
 
Brand: EvoBus
 
Name: Sprinter Transfer, Sprinter Mobility
 
Type / number of model:  EC type-approvals: e13*2007/46*1295, e13*2007/46*1294 Types: KA-UM/UL/UXL-M2, KA-UM/UL/UXL-M3
 
Batch number / Barcode:  The vehicles concerned were manufactured between June 2010 and July 2018.
 
Risk type:  Injuries
 
The inbuilt microphone for tour guide announcements is located in the passenger airbag's inflation zone.
If the airbag were activated, it could be damaged.
 

Measures taken by economic operators: Recall of the product from end users (By: Manufacturer)

 

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