Events

Recall of GE Carescape Patient Monitor B650

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
    15582
  • Event Initiated Date
    2013-11-06
  • 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 manufacturer has determined that selected software versions of b650 and b850 patient monitors have a number of safety related issues including:, 1. non-invasive blood pressure (nibp) auto-cycling will not start, 2. nibp auto-cycling stops when selecting audio & display off, 3. nibp auto-cycling stops when loading data and measuirng nibp at the same time, 4. lost nibp measurements, 5. nibp limit values for infants change when loading a new patient data from a tram module, 6. wrong ecg bandwith in e-psm(p) or e-(p)re(s)tn modules, 7. changing the primary ecg lead selection in the cic pro central station will not change the primary measurement lead in pdm or tram measurement modules, 8. a temp hidden alarm message will not re-activate if a different alarm is acknowledged at icentral, 9. missing audible alarms from remote monitors after broken network connection, 10. missing ecg waveforms on icentral., 11. icentral does not notice a monitor exiting the standby mode, + 14 other issues.
  • Action
    Software to be upgraded

Device

GE Carescape Patient Monitor B650

Manufacturer

GE Healthcare Finland Oy