BEUDAMED
    FDA Recall Terminated

    Leksell Gamma Knife C

    Recall: Z-1533-2010 · Initiated September 1, 2006

    Recall

    Recall Number
    Z-1533-2010
    Event Number
    54850
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2006
    Posted
    April 29, 2010
    Terminated
    December 14, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell Gamma Knife C

    Reason

    Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.

    Action

    Phase 1 - Field Change Order FCO-DOC-06-0003 "Technical Note - Potential risk of dropping the collimator helmet" (dated Aug. 28, 2006) was sent to affected customers as notification of the problem. Phase 2 - Technical Notes Leksell Gamma Knife C version 1.2 (dated July 2006) "Important Notice - Potential risk of dropping the collimator helmet" was sent to all Elekta Service Engineers as notification of the problem. The firm planned to create an upgrade kit for the effected Leksell Gamma Knife C1.2 systems. A service representative from Elekta will contact each site to decide on a suitable implementation schedule.

    Distribution

    Nationwide, Austria, Belgium, Canada, China, Croatia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey.

    Quantity

    88 units