BEUDAMED
    FDA Recall Terminated

    Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system

    Recall: Z-1064-2011 · Initiated July 30, 2009

    Recall

    Recall Number
    Z-1064-2011
    Event Number
    53054
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 30, 2009
    Posted
    February 8, 2011
    Terminated
    April 12, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system

    Reason

    Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.

    Action

    The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.

    Distribution

    Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.

    Quantity

    151 units