Events

Recall of MERGE EYE CARE 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
    48195
  • 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 is being initiated due to an issue when validating a patient using a medical record number (mrn). this system is designed to allow data validation with an mrn only. if the user mistypes the patient mrn at the time of data entry the system could potentially overwrite the existing patient demographics or create an "unknown" patient.

Device

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

Manufacturer

MERGE HEALTHCARE INCORPORATED