Events

Recall of Merge Eye Station and Merge Eye Care PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merge Healthcare, Inc..

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
    76844
  • Event Risk Class
    Class 2
  • Event Number
    Z-1828-2017
  • Event Initiated Date
    2016-04-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154388
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image management, ophthalmic - Product Code NFJ
  • Reason
    During an antivirus program scan of the eye station or eye care pacs, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
  • Action
    The recalling firm issued a letter dated 3/28/2016 via email the week of 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter dated 7/11/2016 was issued to nonresponders.

Device

Merge Eye Station and Merge Eye Care PACS
  • Model / Serial
    All versions
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
  • Product Description
    Merge Eye Station and Merge Eye Care PACS.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.