Events

Recall of Infinity Acute Care System Monitoring - M540

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
    21491
  • Event Initiated Date
    2017-06-07
  • 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 virtium ram may induce a failure that can lead to patient risk (safety issue). it has been determined that the swissbit 4 gb ram modules perform as intended. the virtium ram may induce a failure that can lead to high memory usage thereby delaying touchscreen operations, and also may lead to not annunciating audio or visual alarms on the cockpit only.
  • Action
    Product to be exchanged

Device

Infinity Acute Care System Monitoring - M540

Manufacturer

Draegerwerk AG & Co KGaA