BEUDAMED
    FDA Recall Terminated

    TriFoillmaging Triumph/Triumph II Research CT scanners.

    Recall: Z-2833-2016 · Initiated May 24, 2016

    Recall

    Recall Number
    Z-2833-2016
    Event Number
    74838
    Firm
    Northridge Tri-Modality Imaging
    FEI Number
    3010878127
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 24, 2016
    Terminated
    October 6, 2016
    Address
    9457 de Soto Ave, Chatsworth, CA, 91311-4920

    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)

    Action

    TriFoil lmaging planned action to bring defect into Compliance: 1. All repairs were performed at customer facilities. Customers were contacted by phone to arrange a convenient repair time. 2. TriFoil service engineers installed a collimator on each of the affected cabinet x-ray systems to bring their emission rates into compliance with the emission limit in the performance standard. 3. Full radiation surveys were performed, at maximum exposure settings, to verify each repair was effective. 4. All costs associated with the repair and follow-up testing were paid directly by TriFoil Imaging. CDRH approves the CAP and understands that the CAP was completed on August 29, 2016. For further questions please call (818) 709-2468.

    Distribution

    USA Distribution

    Quantity

    3