Recall of GE Carescape B650 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 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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 advises there are several potential issues with this device;, 1/ the spo2 saturation limit alartm does not always active with the nellcor spo2, 2/ the device may enter into a constant reboot loop causing the monitor to reboot continuously., 3/ the device may reboot when connected to the unity id, 4/ the device may not update the software for power management card., 5/ an insecurely connected or faulty usb cable may cause the monitor to reboot., 6/ there may be printing delays with the prn50 printer, 7/ the device may reboot due to an x server freeze.
  • Action
    Software to be upgraded