Events

Recall of Draeger Infinity Acute Care System (IACS) in Neonatal Mode

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Draegerwerk AG & Co KGaA.

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
    15655
  • Event Initiated Date
    2013-11-21
  • 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
    The manufacturer has determined that a low spo2 (yellow) medium grade alarm which is pased by the user using teh alarm pause function, may cause the central station monitoring the device not to alarm if the spo2 level drops to high grade life threatening (red) alarm. the device itself will alarm.
  • Action
    Software to be upgraded

Device

Draeger Infinity Acute Care System (IACS) in Neonatal Mode

Manufacturer

Draegerwerk AG & Co KGaA