BEUDAMED
    FDA Recall Terminated

    Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA

    Recall: Z-0121-2010 · Initiated September 10, 2009

    Recall

    Recall Number
    Z-0121-2010
    Event Number
    53329
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 10, 2009
    Posted
    November 5, 2009
    Terminated
    December 6, 2010
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA

    Reason

    A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.

    Action

    The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.

    Distribution

    Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.

    Quantity

    97 units