Events

Recall of MCKESSON RADIOLOGY - BASIC WORKSTATION SOFTWARE

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
    146357
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-17
  • 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 for the system to store new studies in a non-unique directory location on the disk resulting in two different patients sharing the same set of images.

Device

MCKESSON RADIOLOGY - BASIC WORKSTATION SOFTWARE
  • Model / Serial
    Model Catalog: MCKESSON RADIOLOGY 12.1.1 (Lot serial: ); Model Catalog: MCKESSON RADIOLOGY 12.0 (Lot serial: ); Model Catalog: HMI 11.9 (Lot serial: ); Model Catalog: HMI 11.8 (Lot serial: ); Model Catalog: HMI 11.7 (Lot serial: ); Model Catalog: HMI 11.6 (Lot serial: ); Model Catalog: HMI 4.6.1 (Lot serial: ); Model Catalog: HMI 11.0.8 (Lot serial: ); Model Catalog: HMI 5.0 SERVICE PACK 5 (Lot serial: ); Model Catalog: HMI 5.0 (Lot serial: ); Model Catalog: HMI 11.5.1 (Lot serial: )
  • Product Description
    Mckesson Radiology - Software;horizon medical imaging management
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY