Events

Recall of MERGE EYE STATION

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
    45821
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-01
  • 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
    Merge healthcare has been made aware of issues regarding connectivity with the q5 or 1500mr digital camera. customers have reported that when opening an eye station capture session the user may receive a message that the camera cannot be found which requires the user to restart the pc. it has also been reported that during a capture session the camera loses its connection.

Device

MERGE EYE STATION
  • Model / Serial
    Model Catalog: MERGE EYE STATION (Lot serial: T5810); Model Catalog: MERGE EYE STATION (Lot serial: T1700)
  • Product Description
    Merge Eye Station
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED