Events

Recall of Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)

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-2013-RN-01075-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01075-1
  • 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
    Investigations have shown that the overheating protection system of the heating element may fail to function under certain circumstances. this could result in a burn or respiratory complications as a result of inhaling smoke. the reported overheating events have been confined to the machines. therefore, the probability of occurrence of harm to person based on available evidence is considered remote.
  • Action
    Getinge is advising customers that a customer service representative will be contacting users to replace the affected overheating protective system. Given the low probability to harm, Getinge is advising that it is considered safe for a normal user who services and uses the machine as intended to continue using the machines while waiting for replacement.

Device

Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination ...
  • Model / Serial
    Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)Manufactured between 2004 and 2008ARTG Number: 125655
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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