BEUDAMED
    FDA Recall Terminated

    Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

    Recall: Z-1030-2011 · Initiated March 10, 2008

    Recall

    Recall Number
    Z-1030-2011
    Event Number
    57570
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2008
    Posted
    February 3, 2011
    Terminated
    August 9, 2012
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

    Reason

    Possible error in the table longitudinal position.

    Action

    Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout. Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites. For questions regarding this recall call 770-670-2548.

    Distribution

    Nationwide Distribution and Puerto Rico

    Quantity

    597 units