BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    Recall: Z-1396-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1396-2018
    Event ID
    79759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 21, 2018
    Classification Date
    April 17, 2018
    Termination Date
    April 10, 2020
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

    Reason

    Surview scan with tube current lower than 30 mA is unable to be initialized.

    Code Info

    Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

    Distribution

    Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

    Quantity

    291