BEUDAMED
    FDA Recall Terminated

    GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    Recall: Z-0805-2012 · Initiated December 2, 2011

    Recall

    Recall Number
    Z-0805-2012
    Event Number
    60933
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 2, 2011
    Posted
    January 18, 2012
    Terminated
    February 22, 2013
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Highland Heights, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    Reason

    Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.

    Action

    Philips Medical System sent a Urgent Medical Device Correction letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following are recommended actions: 1. Please ask your local Philips Service Engineer to ensure that the Auto Delete function is configured to run automatically. 2. Please share this information with all Philips GEMINI TF system operators at your site. 3. Retain this document with your system's instructions for Use Manual. For further information or support concerning this issue please contact your local Philips representative in the United States and Canada at 1-800-722-9377, and follow the recorded menu options to reach Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NY, OH, OR, PA, PR, TN, TX, WA and WV. and the countries of: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Pakistan, Philippines, Poland, Russian Fed, Saudi, Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.

    Quantity

    197 units