BEUDAMED
    FDA Recall Terminated

    PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.

    Recall: Z-1476-2011 · Initiated January 28, 2008

    Recall

    Recall Number
    Z-1476-2011
    Event Number
    57692
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2008
    Posted
    March 2, 2011
    Terminated
    April 21, 2011
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.

    Reason

    PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.

    Action

    Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .

    Distribution

    Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan,

    Quantity

    277 units