Events

Recall of OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    21954
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-06
  • 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
    Omnyx has determined that there is an issue with the digital archive (da) management tool when used with dps 1.3.0 dps 1.3.1 and dynamyx 2.0 versions software. when migrating cases to a new da the da management tool may cause images to improperly appear in the unmatched slide tab and may also change the status of the case from the current status to "awaiting scans.".

Device

OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: OMN-10005056-X (Lot serial: N/A); Model Catalog: 10009061-X (Lot serial: N/A); Model Catalog: 10010766-X (Lot serial: N/A)
  • Product Description
    OMNYX INTEGRATED DPS SOFTWARE;DYNAMYX SOFTWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)