BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare System X-ray Tomography Computed :

    Recall: Z-0376-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0376-2017
    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

    Ingenuity CT, Ingenuity Core, Ingenuity Core 128.

    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