Events

Rappel de Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Invacare Australia Pty Ltd.

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
    RC-2013-RN-00977-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00977-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands.
  • Action
    Invacare is providing distributors with two options to correct the affected joystick. 1) Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare. 2) Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected. For more details, please see http://www.tga.gov.au/safety/alerts-device-invacare-131011.htm This action has been closed-out on 11/04/2016.

Device

Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls
  • Modèle / numéro de série
    Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver ControlsSerial numbers: 06JXXXXXXX to 13CXXXXXXX (the first two digits represent the year and the first letter represents the month i.e., A=January, B=February etc)Affected SPJ+ Joystick models are manufactured between 9 September 2009 to 21 March 2013 and MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) are manufactured between 1 October 2006 to 21 March 2013ARTG Number: 160385
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd