BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..

    Recall: Z-2118-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2118-2016
    Event ID
    74427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2016
    Initiation Date
    April 1, 2016
    Classification Date
    June 30, 2016
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..

    Reason

    Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

    Code Info

    Ingenuity Core128:System Code #728323, Serial numbers: 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014

    Distribution

    US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX

    Quantity

    19