Events

Recall of Getinge 46 Series Washer Disinfector with PACS 300 module

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Getinge Disinfection AB.

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
    15585
  • Event Initiated Date
    2013-11-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • 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 serious injury such as 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
    Product to be modified

Device

Getinge 46 Series Washer Disinfector with PACS 300 module

Manufacturer

Getinge Disinfection AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA