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
    79261
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-30
  • 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 two or more processes attempt to modify the same image folder within fractions of a second the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in data loss within the image folder.

Device

HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING
  • Model / Serial
    Model Catalog: HMI 11.0.8 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5.2 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.6 FR EXP2 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.6 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.5 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.4 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.3 (Lot serial: >10. contact mfg); Model Catalog: MR 12.0 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.9 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.8 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.7 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.6 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0 (Lot serial: >10. contact mfg); Model Catalog: HMI 5 (Lot serial: >10. contact mfg); Model Catalog: HMI 4.6.1 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.7 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5.1 (Lot serial: >10. contac
  • Product Description
    Horizon Medical Imaging Management System
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY