BEUDAMED
    FDA Recall Terminated

    Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.

    Recall: Z-1755-2008 · Initiated December 10, 2007

    Recall

    Recall Number
    Z-1755-2008
    Event Number
    47226
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 10, 2007
    Posted
    September 29, 2008
    Terminated
    May 13, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.

    Reason

    Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.

    Action

    Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.

    Distribution

    Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.

    Quantity

    168 total