Events

Recall of APEXPRO TELEMETRY SYSTEM

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
    119416
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-26
  • 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
    Potential loss of patient monitoring when apexpro telemetry system is used with a "mirrowed" view carescape cic pro in combination monitoring mode which may result in delay of treatment of a cardiac event.

Device

APEXPRO TELEMETRY SYSTEM
  • Model / Serial
    Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: S/N'S A1GQ0243G B1GQ0333G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: M0GQ0133G M0GQ0139G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: C1GQ0377G F1GQ0696G); Model Catalog: CIC3APRO=XXX (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: S/N'S AA104220209GA); Model Catalog: CICV4APRO=X (Lot serial: AA104260532GA D34T2533G); Model Catalog: CIC3APRO=XXX (Lot serial: S/N'S AA104220209GA); Model Catalog: CIC3APRO=XXX (Lot serial: AA104260532GA D34T2533G); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: MANUFACTURER); Model Catalog: APRSRVR16=XXX (Lot serial: >10 NUMBERS); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: >10 NUMBERS); Model Catalog: APRSRVR16=XXX (Lot serial: CONTACT); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: CONTACT); Model Catalog: APRSRVR16=XXX (Lot serial: MANUFACTURER)
  • Product Description
    APEXPRO TELEMETRY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)