BEUDAMED
    FDA Recall Terminated

    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

    Recall: Z-1436-2017 · Initiated January 25, 2017

    Recall

    Recall Number
    Z-1436-2017
    Event Number
    76459
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 25, 2017
    Terminated
    October 6, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

    Reason

    Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

    Action

    Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.

    Distribution

    Nationwide Distribution

    Quantity

    35 systems