BEUDAMED
    FDA Recall Terminated

    Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Recall: Z-3079-2011 · Initiated May 6, 2011

    Recall

    Recall Number
    Z-3079-2011
    Event Number
    58874
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2011
    Posted
    August 29, 2011
    Terminated
    October 2, 2012
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Reason

    A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.

    Action

    ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.

    Distribution

    Nationwide and Puerto Rico

    Quantity

    368