Events

Rappel de Rascal LiteWay Scooter Model 224

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Electric Mobility Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56978
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0416-2011
  • Date de publication de l'événement
    2010-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95193
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Vehicle, motorized 3-wheeled - Product Code INI
  • Cause
    Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. this may result in complete failure of the seat base, causing the user to fall off the vehicle.
  • Action
    The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers. Customers can contact the Rascal Company about this recall at 1-800-662-4548.

Device

Rascal LiteWay Scooter Model 224
  • Modèle / numéro de série
    No expiration date; 510 K - K002616; Device Listing #E394292; LW224, EMC Part #43062300, EMC Part #43062700
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Throughout the US and Canada
  • Description du dispositif
    Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan.
  • Manufacturer
    Electric Mobility Corp

Manufacturer

Electric Mobility Corp
  • Adresse du fabricant
    Electric Mobility Corp, 599 Mantua Boulevard, One Mobility Plaza, Sewell NJ 08080
  • Source
    USFDA