BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1613-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1613-2016
    Event ID
    73977
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novarad Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 18, 2016
    Initiation Date
    November 16, 2015
    Classification Date
    May 6, 2016
    Termination Date
    August 17, 2016
    Address
    752 E 1180 S Ste 200, N/A, American Fork, UT, 84003-3561, United States

    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.

    Code Info

    Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4

    Distribution

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

    Quantity

    2,386