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
    47888
  • 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
    This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user. in the current workflow a user can select to delete a record(s). when that selection is made a confirmation box is presented asking the user if they want to delete the record(s). the user can then either left click on "ok" or press the "enter" key to confirm the action. currently this confirmation defaults to "ok" or "yes". in this workflow a user could inadvertently hit the "enter" key which would delete the images or procedures. once these images or procedures are deleted they are lost permanently with no recovery.

Device

MERGE EYE STATION
  • Model / Serial
    Model Catalog: MERGE EYE STATION (Lot serial: 11.3.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.1); Model Catalog: MERGE EYE STATION (Lot serial: 10.6); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.1); Model Catalog: MERGE EYE STATION (Lot serial: 11.5); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.2); Model Catalog: MERGE EYE STATION (Lot serial: 11.4); Model Catalog: MERGE EYE STATION (Lot serial: 11.6.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.0)
  • Product Description
    Merge Eye Station
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED