BEUDAMED
    FDA Recall Terminated

    Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)

    Recall: Z-0068-06 · Initiated August 18, 2005

    Recall

    Recall Number
    Z-0068-06
    Event Number
    33273
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 18, 2005
    Posted
    October 21, 2005
    Terminated
    October 29, 2008
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)

    Reason

    The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.

    Action

    The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.

    Distribution

    The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.

    Quantity

    19 devices