Events

Recall of Infant Warmer System (IWS)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2016-RN-01189-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01189-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue related to loose screws in the “heater head” of certain infant warmer system (iws) devices. hot screws from the “heater head” of the iws could fall onto the bed if the “heater head” assembly has been improperly serviced. this could result in thermal injury to a patient. to date, two injuries have been reported as a result of this issue.
  • Action
    GE Healthcare is providing users with interim instructions to check the screws on the "Heater Head" are tight. This will form part of the annual Preventative Maintenance check to ensure the screws are tightened. This action has been closed-out on 23/05/2017.

Device

Infant Warmer System (IWS)
  • Model / Serial
    Infant Warmer System (IWS)Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWSARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd