Events

Recall of MERGE PACS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERGE HEALTHCARE INCORPORATED.

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
    127903
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-29
  • 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
    This recall has been initiated due to merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. pacs 6.5.6 introduced the feature to be able to display foreign presentation states however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study they would also be shown if available on the prior comparison studies.

Device

MERGE PACS
  • Model / Serial
    Model Catalog: MERGE PACS (Lot serial: 6.6.1); Model Catalog: MERGE PACS (Lot serial: 6.5.5); Model Catalog: MERGE PACS (Lot serial: 6.6.0); Model Catalog: MERGE PACS (Lot serial: 6.6.1.1); Model Catalog: MERGE PACS (Lot serial: 6.6.2); Model Catalog: MERGE PACS (Lot serial: 6.5.9); Model Catalog: MERGE PACS (Lot serial: 6.5.6); Model Catalog: MERGE PACS (Lot serial: 6.5.7); Model Catalog: MERGE PACS (Lot serial: 6.5.8)
  • Product Description
    Merge PACS
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED