Events

Recall of GE CARESCAPE Monitor B850

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Healthcare Finland Oy.

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
    15630
  • Event Initiated Date
    2013-11-07
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The patient data module (pdm) can sometimes spontaneosuly lose the communication withthe host patient monitor when atached to the f5-01 frame due to an issue with the pdm ethernet communication hardware.Communication is not automatically re-established. loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the pdm module.. the parameters may include ecg, spo2, nibp, co, temperature and respiration.
  • Action
    Product to be modified

Device

GE CARESCAPE Monitor B850

Manufacturer

GE Healthcare Finland Oy