Events

Recall of Getinge Steriliser

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-2018-RN-00196-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00196-1
  • 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
    Getinge has been made aware that certain gss67 sterilizers will not work up to specification due to power supply electrical connection issues. to date, no adverse events have been reported in australia.
  • Action
    Getinge is providing affected users with an upgraded installation manual, service manual and electrical diagrams. For devices shipped prior to 2017 the electrical components of the device will be corrected. Devices shipped after 2017 have already had these components installed.

Device

Getinge Steriliser
  • Model / Serial
    Getinge Steriliser Model Number: GSS67HARTG Number: 139140Getinge Australia - Sterilizer, moist heat, wrapped goods
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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