Events

Recall of Ohmeda Infant Warmers (with Blenders)

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
    15803
  • Event Initiated Date
    2013-12-05
  • 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
    Oxygen and air wall or tank inlet fittings on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen gas concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate in the affected units. this only impacts ge resuscitation systems with blender.
  • Action
    Product to be modified

Device

Ohmeda Infant Warmers (with Blenders)

Manufacturer

Ohmeda Medical Inc