Events

Recall of Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)

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

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-2017-RN-01185-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01185-1
  • 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
    Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. the top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. the consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the us fda, 3 serious injuries occurred (2 broken bones and 1 laceration).
  • Action
    Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction. For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-system

Device

Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)
  • Model / Serial
    Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)Model: C300 Corpus IISerial Numbers: 2537002437, 2537002471, 2537002476, 2537002514, 2537002746, 2537002891 and 2537002956Model: C350 Corpus IISerial Number: 43203511Model: C500 Corpus IISerial Number: 15702655 Model: C500 Corpus II LRSerial Numbers: 2557000160 and 2557000185ARTG Number: 224603
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia