BEUDAMED
    FDA Recall Terminated

    Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system.

    Recall: Z-0646-2009 · Initiated November 6, 2008

    Recall

    Recall Number
    Z-0646-2009
    Event Number
    50480
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    KPQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 6, 2008
    Posted
    January 13, 2009
    Terminated
    December 9, 2010
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system.

    Reason

    Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.

    Action

    Firm has reissued the Urgent Medical Device Customer Letter regarding the belt replacement and a reminder message to replace the belts yearly during the annual Preventative Maintenance. The letter requests that customers follow the guidelines, which consist of making any required SAD adjustments utilizing the Image Intensifier drive, the X-Ray Head Drive, or both; being vigilant of any change in the type or level of noise from either of the drive belt assemblies while they are in use as this may be an indication of wear; discontinuing clinical operation if there is any doubt, and contacting their local Siemens Service organization to inspect the belts. Currently, the firm is distributing the current belt kit to replace the entire installed base of active SIMVIEW Simulators (3000 and NT models).

    Distribution

    Worldwide Distribution

    Quantity

    223 units