Events

Recall of HORIZON CARDIOLOGY HEMO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHANGE HEALTHCARE CANADA COMPANY.

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
    97414
  • Event Risk Class
    III
  • Event Initiated Date
    2010-12-24
  • 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
    Mckesson has identified a rare scenario where the system's monitoring mechanism might initiate a system restart during a clinical procedure. as a result a labelling update is initiated.

Device

HORIZON CARDIOLOGY HEMO
  • Model / Serial
    Model Catalog: HCH-200 (Lot serial: >10 numbers contact mfg)
  • Product Description
    Horizon Cardiology Hemo System
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY