Events

Rappel de Device Recall Rascal Scooter

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
    37880
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0175-2008
  • Date de mise en oeuvre de l'événement
    2007-03-29
  • Date de publication de l'événement
    2007-11-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52042
  • 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
    Powerchair Motorized Vehicles - Product Code INI
  • Cause
    Seat and/or lift actuator problems: 1) models equipped with a seat lift, the mast screw and washer holding the seat lift actuator in place will loosen break off or fall out; 2) models assembled with seat lift actuator or seat post mounting bolts, the seat may wobble or the seat will break off from the vehicle; 3) models using seat-on lifting brackets with a hoist to raise an emc vehicle equipped w.
  • Action
    Consumers were sent an Urgent Medical Device Recall Notification on October 12, 2007, requesting that they immediately respond to the Medical Device Recall by calling EMC at 1-800-814-4365, or by returning an enclosed Recall Response Form, or by responding on-line at www.EMCIT.NET/801B. The Notification address three important safety issues on 1) Seat Lift Actuator Mast Screws and Washers; 2) Seat Lift Actuator or Seat Post Mounting Bolts and; 3) Incorrect Seat-On Lift Bracket Installation. Corrections to the devices will be made by the nearest Service Representatives, by scheduled in-home repairs, or return of the rear section of the scooter with EMC providing shipping material and freight payment.

Device

Device Recall Rascal Scooter
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide: to consumers via direct purchase from Electric Mobility Corporation.
  • Description du dispositif
    Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Electric Mobility Corporation (EMC), Sewell, New Jersey 08080
  • 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