Events

Recall of PowerPro Ambulance Cots

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-00754-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00754-1
  • 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
    Stryker has become aware that the supplier has made a manufacturing transfer from their tier two supplier which affected the quality of the boards supplied to stryker. as a result of workmanship issues, the boards have the potential to short circuit and overheat. there is a high probability of limited (minor, transient) harm, specifically minor respiratory irritation, not requiring medical intervention and untended lowering or cot dropping to the lowest position (no cot tip). faulty units will not work as intended. there have been no reports of injury associated with this issue.
  • Action
    Stryker is advising users to inspect stock for the affected lot numbers. Any affected devices will be corrected, and can continue to be used until the correction has been completed. This action has been closed-out on 15/03/2018.

Device

PowerPro Ambulance Cots
  • Model / Serial
    PowerPro Ambulance Cots Catalogue Number: 6506000000Multiple Lot NumbersARTG Number: 197659
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA