BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare System X-ray Tomography Computed :

    Recall: Z-0375-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0375-2017
    Event ID
    75551
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    March 15, 2016
    Classification Date
    November 22, 2016
    Termination Date
    September 9, 2020
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Healthcare System X-ray Tomography Computed :

    Reason

    It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

    Code Info

    Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, Brilliance Big Bore.

    Distribution

    USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.

    Quantity

    1363