BEUDAMED
    FDA Recall Terminated

    NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

    Recall: Z-2151-2016 · Initiated May 9, 2013

    Recall

    Recall Number
    Z-2151-2016
    Event Number
    74556
    Firm
    Novarad Corporation
    FEI Number
    1000117423
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 9, 2013
    Terminated
    December 1, 2016
    Address
    752 E 1180 S, Ste 200, American Fork, UT, 84003-3561

    Description

    NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

    Reason

    Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

    Action

    Consignees were notified on 05/09/13 via letter and email to upgrade software and to turn off streaming function.

    Distribution

    Worldwide distribution including US nationwide. No Canadian distribution.

    Quantity

    2695