BEUDAMED
    FDA Enforcement Class II 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 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2151-2016
    Event ID
    74556
    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
    July 20, 2016
    Initiation Date
    May 9, 2013
    Classification Date
    July 11, 2016
    Termination Date
    December 1, 2016
    Address
    752 E 1180 S Ste 200, American Fork, UT, 84003-3561, United States

    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.

    Code Info

    All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0

    Distribution

    Worldwide distribution including US nationwide. No Canadian distribution.

    Quantity

    2695