Events

Recall of Infant Warmers

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

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
    21726
  • Event Initiated Date
    2017-07-26
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The manufacturer has recently become aware of a potential safety issue related to loose screws in the heater head of certain infant warmer system devices. hot screws from the heater head of the iws could fall onto the bed if the heater head assembly has been improperly serviced.
  • Action
    Manufacturer to issue advice regarding use

Device

Infant Warmers
  • Model / Serial
    Model: , Affected: Affected model numbers: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300 IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.
  • Manufacturer
    Ohmeda Medical Inc

Manufacturer

Ohmeda Medical Inc