BEUDAMED
    FDA Recall Terminated

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    Recall: Z-1678-2020 · Initiated February 18, 2020

    Recall

    Recall Number
    Z-1678-2020
    Event Number
    85161
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    February 18, 2020
    Terminated
    February 9, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    Reason

    Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

    Action

    A Customer Safety Advisory Notice was sent to all affected consignees on 2/18/2020 via Adobe Mega Sign or USPS certified mail. The notice describes the interlock scenarios, provides user instructions, and warns the user of potential risks. The interlock scenarios are as follows: MONITOR 2: Monitor 2 total dose coincidence. Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment. TREATMENT TIME: Preset treatment time coincidence with actual treatment time. Intent: This interlock is intended to prevent overdose if preset treatment time is exceeded. MONITOR SYNC (SW): Excessive accumulated dose deviation detected between the primary and the secondary dose monitoring systems. Intent: This interlock is intended to prevent patient mistreatment due to the inaccurate monitoring of delivered dose. When one or more of the above described interlocks occur, it may be assumed that there is an error in the dose monitor system.The Consumer Safety Advisory Notice states that the Operator's Manual Instructions Update document should be added to the product's manual and all users should be informed of the issues.

    Distribution

    Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

    Quantity

    1012