Events

Recall of Draeger Air-Shields Resuscitaire Radiant Warmer

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Draeger Medical Systems 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
    20281
  • Event Initiated Date
    2016-06-16
  • 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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Reason
    When the babytherm is operated in skin temperature mode with skin temperature sensor, but without a patient, the automatic controls monitoring skin temperature are not activated and the radiant warmer operates continuously at a high output level. during this forced continuous operation underder high thermal load, the heating element ages faster.
  • Action
    Manufacturer to issue advice regarding use

Device

Draeger Air-Shields Resuscitaire Radiant Warmer

Manufacturer

Draeger Medical Systems Inc