BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    Recall: Z-1029-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1029-2013
    Event ID
    64393
    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 10, 2013
    Initiation Date
    December 20, 2012
    Classification Date
    April 1, 2013
    Termination Date
    June 18, 2013
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    Reason

    Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.

    Code Info

    Model #: 882456; Serial #: 2004

    Distribution

    Distributed to one customer in Ohio.

    Quantity

    1