Events

Alerte De Sécurité sur Breeze C Scooters

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Afikim Electric Vehicles.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-02
  • Date de publication de l'événement
    2013-10-02
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: afikim breeze c scooters the united states food and drug administration (fda) has issued a medical device safety alert concerning breeze c scooters, manufactured by afikim electric vehicles. the affected products are identified as follows:- serial no.: 10390024, 11390060, 11490426, 12390107, 12490181, 10390025, 11390061, 11490433, 12390117, 12490182, 10390029, 11390069, 11490435, 12390120, 12490183, 10390030, 11390074, 11490445, 12490169, 12490184, 10390034, 11390095, 12390096, 12490170, 12490185, 10390037, 11390101, 12390097, 12490172, 12490186, 10490100, 11490111, 12390098, 12490173, 12490187, 10490108, 11490147, 12390099, 12490174, 12490188, 10490111, 11490176, 12390101, 12490175, 12490189, 10490113, 11490189, 12390102, 12490176, 12490190, 10490119, 11490277, 12390103, 12490177, 12490191, 10490121, 11490304, 12390104, 12490178, 12490192, 10490124, 11490305, 12390105, 12490179, 12490193, 11390058, 11490425, 12390106, 12490180 the products were manufactured from 02/07/2010 to 24/07/2012 and distributed from 15/09/2010 to 25/07//2013. during product testing, the manufacturer became aware of a potential scenario where an internal potentiometer wiper could become disconnected due to extensive wear. if this were to occur the device could continue to drive forward at a slow speed of approximately 2-4 mph and the only way to stop the device would be by turning off the main key switch. there is no injuries have been reported to date. the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370577.Htm http://www.Fda.Gov/safety/recalls/ucm370503.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

Breeze C Scooters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Afikim Breeze C Scooters
  • Manufacturer
    Afikim Electric Vehicles

Manufacturer

Afikim Electric Vehicles