BEUDAMED
    FDA Recall Terminated

    Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-0784-2012 · Initiated December 1, 2011

    Recall

    Recall Number
    Z-0784-2012
    Event Number
    60697
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 1, 2011
    Posted
    January 17, 2012
    Terminated
    December 2, 2013
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.

    Action

    Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    327 Active Devices - all models