BEUDAMED
    FDA Recall Terminated

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    Recall: Z-1017-2017 · Initiated December 9, 2016

    Recall

    Recall Number
    Z-1017-2017
    Event Number
    75602
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 9, 2016
    Terminated
    March 24, 2021
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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). Versions: 11.6.0 and prior

    Reason

    This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

    Action

    Consignees were sent on 12/9/2016 a Merge "Urgent Medical Device Recall" letter. The letter was addressed to Office Manager and Recall # 216-078. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested consignees 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 [email protected]. E-mails to be sent to consignees on 12/19/2016.

    Distribution

    US: Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware, District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming. OUS: Czech Republic Algeria Belgium Brazil Canada Denmark France Germany Greece India Israel Italy Korea, Republic of Luxembourg Netherlands Poland Russian Federation Singapore United Kingdom

    Quantity

    1597 (1451 US; 146 OUS)