Events

Rappel de Powered Wheelchairs Joystick

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

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-2018-RN-00497-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-05-18
  • 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-2018-RN-00497-1
  • 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
    Magic mobility has been notified of a component issue resulting in the direct actuator control switching, through the jack input socket, to not function correctly.This issue may cause either an incorrect switch/actuator operation or an inoperable external switch/actuator. at the time of dispatch from magic mobility, any wheelchairs fitted with this joystick did not require the use of the jack input socket. the wheelchairs performance is not compromised in its despatched state.However, if in the future, a client wishes to use the jack for a switch, then the jack may not work correctly. this issue would be detected immediately and therefore poses no safety risk.
  • Action
    Magic Mobility has identified and quarantined all affected serial numbers. Those units currently with customers are identified and a replacement scheme for the affected component has been initiated. Magic Mobility will be contacting affected customers directly.

Device

Powered Wheelchairs Joystick
  • Modèle / numéro de série
    Powered WheelchairsJoystickPart Number: D51581 R-NET CJSM-L-SWSerial Numbers: BN18032803, BN18032873 and BN18032894ARTG Number: 118288
  • Manufacturer
    Red Milawa Pty Ltd T/A Magic Mobility

Manufacturer

Red Milawa Pty Ltd T/A Magic Mobility