Events

Rappel de Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style back

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-2015-RN-00356-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-04-24
  • 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-2015-RN-00356-1
  • 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 recently identified a potential pinch point affecting the wiring of the listed power wheel chairs. there is a possibility that if the slack in the wires is not routed and secured correctly, and with flexing of the back pan under the user’s weight, the headrest knob or clamp bracket may pinch, damage or cut the wire creating a hazard. smoking, sparking, burning or fire may occur if any wire in this area is repetitively pinched, at the same location, over a period of time. not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly. invacare has received one complaint and there have not been any reported events involving injury associated with this issue.
  • Action
    Dealers are advised to identify wheelchair owners and notify them of this issue and proposed actions using the consumer letters provided by Invacare. Dealers are also advised to contact their respective customers to schedule an appointment to inspect the potentially impacted power wheelchair as soon as possible. A visual inspection of the wiring shall be conducted for each impacted chair and where required the wiring will be (corrected) routed and secured in accordance with the Power Wheelchair Wiring Guide provided to dealers. For more details, please see http://www.tga.gov.au/alert/invacare-tdx-and-storm-series-power-wheelchairs . This action has been closed-out on 18/08/2016.

Device

Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with For...
  • Modèle / numéro de série
    Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style backModels:TDX Series: TDXSP, TDXSP-AUS, TDX SR-AUS & TDX SRStorm Series: 3GTQ-MCG, STORM TORQUE, STORM TORQUE-AUS, RANGERX, 3GRX-CG, ARROW 3G & 3GAR-TSMultiple serial numbersManufactured from October 1, 2006 - July 31, 2014ARTG number: 160385
  • Classification du dispositif
    Physical Medicine Devices
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd