Events

Recall of Getinge HS33 Sterilsers

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-2017-RN-00251-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00251-1
  • 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 identified an issue with getinge hs33 manual door sterilisers, which can potentially cause the door with manual mechanism to unseal during the process. this can cause potential steam leakage. this potential for malfunction is caused by the design of the door hook which is a part of the door locking mechanism (part number 4839900). when the door has been closed and the sterilisation process has started, the leak may occur through the door gap, however the door will not slide down as the clamping brakes located on both sides of the door hinder the slide down. in case the process must be interrupted due to safety reasons, the emergency stop button will immediately cut off steam supply to the chamber. getinge's investigation which included risk analysis and evaluation of the worst-case scenario concluded that it is highly unlikely the malfunction would cause or contribute to an injury.
  • Action
    Getinge has developed a new design of the component (part no 6011000223) to prevent device door to unseal during the process. This action is to replace the existing door hook (part no 4839900) with the new and corrected design.

Device

Getinge HS33 Sterilsers
  • Model / Serial
    Getinge HS33 SterilsersModel Numbers: 978053XXX, 978055XXX and 6011978043XXXSerial Numbers: 11101581, 12031135, 12171741, 12481961, 13122119, 13402211, 13412218, 13412224, 13452238, 14483126ARTG Number: 275198
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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