BEUDAMED
    FDA Recall Terminated

    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.

    Recall: Z-1049-2015 · Initiated January 22, 2015

    Recall

    Recall Number
    Z-1049-2015
    Event Number
    70365
    Firm
    Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany
    FEI Number
    3001362763
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    January 22, 2015
    Posted
    February 4, 2015
    Terminated
    March 4, 2016

    Description

    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.

    Reason

    Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.

    Action

    Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.

    Distribution

    Nationwide Distribution.

    Quantity

    985