Events

Recall of GE CareScape Patient Monitor, Multi-Parameter

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
    16868
  • Event Initiated Date
    2014-06-24
  • 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
    When connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2 the pdm may not start communicating to the monitor and loss of the pdm parameters could occur., this issue happens after the following sequence of events:, 1. the pdm is connected to a transport pro or solar monitor., 2. at least one arrhythmia or st-change snapshot is saved in the pdm., 3. the pdm is then connected to the carescape bx50 monitor., 4. more than 740 arrhythmia or st-change snapshots are then saved in the pdm., 5. the pdm is then disconnected and connected back to the carescape bx50 monitor.
  • Action
    Software to be upgraded

Device

GE CareScape Patient Monitor, Multi-Parameter
  • Model / Serial
    Model: Models: B850, B650, B450, Affected: , Software version: Version 2 software
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy