BEUDAMED
    FDA Recall 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 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-1029-2013
    Event Number
    64393
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 20, 2012
    Posted
    April 1, 2013
    Terminated
    June 18, 2013
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    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.

    Action

    Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated December 19, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. A Philips Service Engineer will contact the customer for implementation of the software update on the affected system.

    Distribution

    Distributed to one customer in Ohio.

    Quantity

    1