Events

Recall of Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ausmedic Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00453-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00453-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Instances of frame failures have been identified where considerable heavy usage of the wheelchair has instigated a fracture in the aluminium tubing that supports the rear drive motors.
  • Action
    An upgrade kit has been supplied and fitted by a service engineer to reduce the potential for frame fracture occurring. For more details, please see http://www.tga.gov.au/safety/alerts-device-viper-wheelchairs-131003.htm .

Device

Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007
  • Model / Serial
    Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007This recall action was conducted prior to approval of the recall strategy by the Therapeutic Goods Administration.
  • Manufacturer
    Ausmedic Australia Pty Ltd

Manufacturer

Ausmedic Australia Pty Ltd