BEUDAMED
    FDA Enforcement Class II Terminated

    TriFoillmaging Triumph/Triumph II Research CT scanners.

    Recall: Z-2833-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2833-2016
    Event ID
    74838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northridge Tri-Modality Imaging,
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    May 24, 2016
    Classification Date
    September 30, 2016
    Termination Date
    October 6, 2016
    Address
    9457 de Soto Ave, N/A, Chatsworth, CA, 91311-4920, United States

    Description

    TriFoillmaging Triumph/Triumph II Research CT scanners.

    Reason

    The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 CFR 1020.40 (Cabinet X-ray standards)

    Code Info

    n/a

    Distribution

    USA Distribution

    Quantity

    3