Events

Rappel de CORPUS II

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 Permobil, Ab.

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
    78079
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0005-2018
  • Date de mise en oeuvre de l'événement
    2017-09-01
  • Date de publication de l'événement
    2017-10-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158627
  • 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
    Wheelchair, powered - Product Code ITI
  • Cause
    There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
  • Action
    The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows: LOG INTO CORRECTION WEB PORTAL Immediately log into www.permobilfsa.com. Log in with the following ID and Password. CEASE DISTRIBUTION OF EXISTING INVENTORY Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs. IMMEDIATELY PERFORM INSPECTION If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking. If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed. If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction. PERFORMING THE CORRECTION You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting. The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair. Please contact your Permobil sales representative if you have any questions regarding this correction.

Device

CORPUS II
  • Modèle / numéro de série
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
  • Description du dispositif
    Electric Wheelchairs: || a) C300 CORPUS II || b) C350 CORPUS II || c) C400 CORPUS II || d) C400 CORPUS II LR || e) C500 CORPUS II || f) C500 CORPUS II LR
  • Manufacturer
    Permobil, Ab

Manufacturer

Permobil, Ab
  • Adresse du fabricant
    Permobil, Ab, Arvaltsvagen 10, Box 120, Timra Sweden
  • Société-mère du fabricant (2017)
    Investor AB
  • Source
    USFDA