BEUDAMED
    FDA Recall Terminated

    Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Recall: Z-0305-2012 · Initiated March 9, 2011

    Recall

    Recall Number
    Z-0305-2012
    Event Number
    60121
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 9, 2011
    Posted
    November 29, 2011
    Terminated
    August 9, 2012
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Reason

    If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.

    Action

    Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.

    Distribution

    Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico

    Quantity

    56