Events

Recall of HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM

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
    88742
  • Event Risk Class
    II
  • Event Initiated Date
    2007-07-16
  • 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
    A situation seen using a horizon rad station advanced workstation where an unsaved voxar 3d version 4.2 or 6.2 snapshot in a study that is swept then closed gets saved in the next study that is opened & closed.

Device

HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM
  • Model / Serial
    Model Catalog: ULTRAPACS (Lot serial: N/A)
  • Product Description
    HORIZON MEDICAL IMAGING 11.0.x Systems
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY