Events

Rappel de Permobil Chairman 2K powered wheelchair

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 Permobile 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
    25733
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0834-03
  • Date de mise en oeuvre de l'événement
    2003-03-07
  • Date de publication de l'événement
    2003-05-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26388
  • 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
    One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
  • Action
    Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold. This list also includes the name of the individual for whom the wheelchair was specified at the time of order from Permobil Inc, where applicable. The Permobil field representatives have been trained to perform the upgrade and have been provided the necessary tools to complete the task. They will also train and supervise the Dealer''s technicians who will effect the upgrade at the Dealer level, as the field representatives will rely upon their Dealer network to complete the upgrades in a timely fashion.

Device

Permobil Chairman 2K powered wheelchair
  • Modèle / numéro de série
    Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada and Puerto Rico
  • Description du dispositif
    Permobil Chairman 2K powered wheelchair
  • Manufacturer
    Permobile Inc.

Manufacturer

Permobile Inc.
  • Adresse du fabricant
    Permobile Inc., 6961 Eastgate Blvd, Lebanon TN 370906005
  • Source
    USFDA