Events

Recall of COMBOLAB SYSTEM - MAIN UNIT

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
    36062
  • Event Risk Class
    II
  • Event Initiated Date
    2007-04-20
  • 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
    Under certain conditions there could be a potential loss of real-time monitoring with the cardiolab/maclab/combolab electrophysiology and hemodynamic monitoring systems.

Device

COMBOLAB SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: INWSYS-XXX-XX-X (Lot serial: SBT05470222GA & SBT06281068GA); Model Catalog: INS-XXXXXXX-XXXXXXX (Lot serial: SBT05470222GA & SBT06281068GA); Model Catalog: INHW-XXXXXXX-XXXX (Lot serial: SBT05470222GA & SBT06281068GA); Model Catalog: INS-XXXXXXX-XXXXXXX (Lot serial: >10 NUMBERS); Model Catalog: INHW-XXXXXXX-XXXX (Lot serial: >10 NUMBERS); Model Catalog: INWSYS-XXX-XX-X (Lot serial: MANUFACTURER); Model Catalog: INS-XXXXXXX-XXXXXXX (Lot serial: MANUFACTURER); Model Catalog: INWSYS-XXX-XX-X (Lot serial: >10 NUMBERS); Model Catalog: INHW-XXXXXXX-XXXX (Lot serial: MANUFACTURER); Model Catalog: INHW-XXXXXXX-XXXX (Lot serial: CONTACT); Model Catalog: INS-XXXXXXX-XXXXXXX (Lot serial: CONTACT); Model Catalog: INWSYS-XXX-XX-X (Lot serial: CONTACT); Model Catalog: INHW-XXXXXXX-XXXX (Lot serial: AA504361067GA SBT06110675GA); Model Catalog: INS-XXXXXXX-XXXXXXX (Lot serial: SBT06190826GA ABT06180783GA); Model Catalog: INWSYS-XXX-XX-X (Lot serial: AA504361067GA SBT06110675GA); Model Catalog: INHW-XXXXXXX-XX
  • Product Description
    COMBOLAB SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)