Events

Recall of CARESCAPE MONITOR B850 SYSTEM - C1 CPU

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    22668
  • Event Risk Class
    I
  • Event Initiated Date
    2011-03-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    1)cardiac output values may be calculated incorrectly if default catheter settings used 2)ecg "leads off" alarm may not be activated with a specific user workflow which could lead to complete loss of ecg monitoring.

Device

CARESCAPE MONITOR B850 SYSTEM - C1 CPU
  • Model / Serial
    Model Catalog: 2020913-002 (Lot serial: >100 NUMBERS); Model Catalog: 2020913-003 (Lot serial: CONTACT); Model Catalog: 2020913-003 (Lot serial: MANUFACTURER); Model Catalog: 2020913-003 (Lot serial: >10 NUMBERS); Model Catalog: 2020913-002 (Lot serial: CONTACT); Model Catalog: 2020913-002 (Lot serial: MANUFACTURER)
  • Product Description
    CARESCAPE MONITOR B850 SYSTEM - C1 CPU
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)