BEUDAMED
    FDA Recall Terminated

    Synergy XVI Intended for radiation therapy treatment.

    Recall: Z-1724-2014 · Initiated April 23, 2014

    Recall

    Recall Number
    Z-1724-2014
    Event Number
    68255
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 23, 2014
    Posted
    June 16, 2014
    Terminated
    July 17, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Synergy XVI Intended for radiation therapy treatment.

    Reason

    XVI can incorrectly calculate the target position of the treatment table.

    Action

    Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected. 4. The update will be mandatory and will be made at no cost to the users. CDRH approves this CAP. You may proceed with implementation of the CAP. For further questions please call (770) 670-2422.

    Distribution

    Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.

    Quantity

    380 US