Events

Recall of HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING

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
    71268
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-03
  • 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
    When archiving task is stopped and then started in quick succession software defect causes incorrect study to be presented to radiologist while requested study gets erroneously deleted without being archived.

Device

HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING
  • Model / Serial
    Model Catalog: HMI 11.9 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 11.8 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 4.5 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 4.6.1 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 5 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 11.0 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 11.5 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HMI 11.7 (Lot serial: ALL LOTS. CONTACT MFG); Model Catalog: HIM 11.6 (Lot serial: ALL LOTS. CONTACT MFG)
  • Product Description
    Horizon Medical Imaging products
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY