BEUDAMED
    FDA Recall Terminated

    Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

    Recall: Z-0014-2009 · Initiated June 20, 2008

    Recall

    Recall Number
    Z-0014-2009
    Event Number
    49022
    Firm
    Intraop Medical Corporation
    FEI Number
    3001874253
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 20, 2008
    Posted
    October 3, 2008
    Terminated
    April 5, 2011
    Address
    570 Del Rey Ave, Sunnyvale, CA, 94085-3528

    Description

    Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

    Reason

    Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.

    Action

    Recall initiated on 06/20/2008, advising users via Advisory Notice that a safety upgrade would be available. Two options are given to either self inspect the product or schedule an Intraop Authorized Field Service Engineer to visit their facility to perform the inspection. The letter notes that if no nut failure was evident, the machine could still be used. The firm continues to send retrofit kits.

    Distribution

    Worldwide Distribution

    Quantity

    24 units