BEUDAMED
    FDA Recall Terminated

    Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

    Recall: Z-0971-2008 · Initiated October 2, 2007

    Recall

    Recall Number
    Z-0971-2008
    Event Number
    46200
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 2, 2007
    Posted
    April 30, 2008
    Terminated
    December 24, 2008
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

    Reason

    Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im

    Action

    On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.

    Distribution

    Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.

    Quantity

    7 units