Events

Rappel de Device Recall Manual Wheelchairs with Transit System Option

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 Sunrise Medical Inc.

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
    51260
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0831-2011
  • Date de mise en oeuvre de l'événement
    2009-02-02
  • Date de publication de l'événement
    2010-12-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79491
  • 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
    Mechanical wheelchair - Product Code IOR
  • Cause
    The stabilizer bar was inadvertently omitted during the manufacturing process.
  • Action
    An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.

Device

Device Recall Manual Wheelchairs with Transit System Option
  • Modèle / numéro de série
    Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Description du dispositif
    Manual Wheelchairs with Transit System Option, || Model: Quickie LXI (EILXI), || Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA || Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • Adresse du fabricant
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA