Events

Recall of GE Carescape Bx50 Patient Monitor

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Medical Systems Information Technologies.

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
    17251
  • Event Initiated Date
    2014-09-01
  • 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
    If the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a "patient discharge" or during active monitoring, the ecg waveform and its associated waveform parameters could be analyzed incorrectly., the ecg heart rate (hr) parameter data, the ecg waveform analysis and other ecg parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. as a result of the abnormal analysis of data, the alarms for serious conditions may not be triggered appropriately. the issue potentially affects heart rate, ecg st segment analysis, 12 lead ecg analysis; ecg, spo2, respiration and invasive blood pressure waveforms both locally and at cic; and data displayed at cic may show data drop out. neither bedside nor cic data can reliably represent the parameters being measured.
  • Action
    Software to be upgraded

Device

GE Carescape Bx50 Patient Monitor

Manufacturer

GE Medical Systems Information Technologies