BEUDAMED
    FDA Recall Terminated

    ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.

    Recall: Z-1888-2009 · Initiated April 9, 2009

    Recall

    Recall Number
    Z-1888-2009
    Event Number
    52723
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 9, 2009
    Posted
    September 24, 2009
    Terminated
    April 12, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.

    Reason

    Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment

    Action

    Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.

    Distribution

    Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.

    Quantity

    53 units