BEUDAMED
    FDA Enforcement Class II Terminated

    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

    Recall: Z-2678-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2678-2014
    Event ID
    69102
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    January 9, 2007
    Classification Date
    September 22, 2014
    Termination Date
    November 6, 2015
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

    Reason

    When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.

    Code Info

    Model 728243 Software version 2.2.1 and 2.2.2

    Distribution

    Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.

    Quantity

    61