BEUDAMED
    FDA Recall Terminated

    NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

    Recall: Z-1613-2016 · Initiated November 16, 2015

    Recall

    Recall Number
    Z-1613-2016
    Event Number
    73977
    Firm
    Novarad Corporation
    FEI Number
    1000117423
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 16, 2015
    Posted
    May 6, 2016
    Terminated
    August 17, 2016
    Address
    752 E 1180 S, Ste 200, American Fork, UT, 84003-3561

    Description

    NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

    Reason

    The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

    Action

    Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.

    Distribution

    Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.

    Quantity

    2,386