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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    Recall: Z-1142-2017 · Initiated December 9, 2016

    Recall

    Recall Number
    Z-1142-2017
    Event Number
    75149
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    HKI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 9, 2016
    Terminated
    June 19, 2018
    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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    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 [email protected]. E-mails to be sent to consignees on 12/19/2016. For further questions, please call (262) 367- 0700.

    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.

    Quantity

    182 capture stations