Events

Recall of Device Recall Merge Eye Station

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
    75149
  • Event Risk Class
    Class 2
  • Event Number
    Z-1142-2017
  • Event Initiated Date
    2016-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149463
  • 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
    Camera, ophthalmic, ac-powered - Product Code HKI
  • Reason
    Merge received reports of merge eye station being unable to capture images of the eye as expected per the intended use of the product. merge is recalling product from the field to reduce the risk to patient health.
  • Action
    Merge sent an Urgent Medical Device Recall letter on December 9, 2016. The letter was addressed to Office Manager . The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested customers to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to recall@merge.com. E-mails to be sent to consignees on 12/19/2016. For further questions, please call (262) 367- 0700.

Device

Device Recall Merge Eye Station
  • Model / Serial
    136 T1700 Capture Stations 46 T5810 Capture Stations
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.
  • Product Description
    Merge Eye Station. || f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). || Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.