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
    55949
  • 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 because the cross reference lines a.K.A cut lines or localizer lines may not display properly. this is due to math error when calculating the cut line position for studies with extremely high precision in the dicom tag image orientation patient (0020 0037) containing values of greather than 15 significant digits. when the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study.

Device

MERGE PACS
  • Model / Serial
    Model Catalog: MERGE PACS (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Description
    MERGE PACS
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED