Events

Recall of Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Otto Bock 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-2014-RN-00458-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00458-1
  • 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
    During the course of on-going market observations the front caster fork complaint rate of the three wheelchairs has increased. a detailed analysis of the reports shows that the caster forks may, in unusual circumstances, break when repeatedly driven over or against street curbs.
  • Action
    Ottobock Healthcare is replacing the caster fork on all affected A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs. Product corrections are to be carried out by the wheelchair dealer. For more details, please see http://www.tga.gov.au/safety/alerts-device-ottobock-power-wheelchairs.htm .

Device

Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between...
  • Model / Serial
    Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013ARTG Number: 177246
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd