Events

Recall of Heater Cooler Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Maquet Cardiopulmonary AG.

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
    22177
  • Event Initiated Date
    2017-11-01
  • 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
    Even though hcu 20 and hcu 30 do not emit contaminated aerosols, the manufacturer developed and validated new safe and user-friendly water quality management procedures to be implemented on all hcu 20 and hcu 30 systems in the field.
  • Action
    Instructions for use to be updated

Device

Heater Cooler Unit

Manufacturer

Maquet Cardiopulmonary AG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA