BEUDAMED
    FDA Enforcement Class II 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 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1049-2015
    Event ID
    70365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    January 22, 2015
    Classification Date
    February 4, 2015
    Termination Date
    March 4, 2016
    Address
    Carl Zeiss Promenade 10, N/A, Jena, N/A, N/A, Germany

    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.

    Code Info

    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)

    Distribution

    Nationwide Distribution.

    Quantity

    985