BEUDAMED
    FDA Recall Terminated

    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

    Recall: Z-2626-2016 · Initiated July 13, 2016

    Recall

    Recall Number
    Z-2626-2016
    Event Number
    74840
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    July 13, 2016
    Posted
    August 23, 2016
    Terminated
    January 24, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

    Reason

    Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

    Action

    Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.

    Distribution

    Distributed to: MI, NY, CA, KY, ND, NE

    Quantity

    4 systems