BEUDAMED
    FDA Recall Terminated

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    Recall: Z-1064-2014 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1064-2014
    Event Number
    65450
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 28, 2013
    Posted
    March 14, 2014
    Terminated
    January 17, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    Reason

    Customers are resetting the default values outside recommended factory settings.

    Action

    The firm, Elekta, sent an "Important Field Safety Notice (IFSN 200 01 103 073 - Electron Applicator Auto-Tracking Defaults)" released on May 28, 2013 and is in the process of being distributed to all customers. The Notice requests users to please adhere to the instructions and advice given in manuals and system dialogues, which explicitly state that a change to auto-tracking values could compromise compliance with safety standards and can cause increased unwanted radiation dose to the patient. All machines should be checked against the default settings attached. If the actual settings are greater than the default settings, then Elekta's recommendation is that the default settings should b re-applied and all relevant physics checks (e.g. beam uniformity, output factor) performed. If, however, auto-tracking values are increased beyond their factory-set defaults, then electron applicator radiation leakage measurements should also be made to ensue that the system remains compliant to IEC safety. All users of Desktop Pro and Integrity 1.1 software will receive a mandatory upgrade to Integrity 1.2 (released 28-Jan-14. The upgrade path to Integrity 1.2 differs depending on system configurations at each customers site, therefore Elekta has released three separate Important Field Safety Modifications in order to upgrade all customers successfully. Important Field Safety Notice 200 01 501 036 Important Field Safety Modifications 200 02 501 037 Applicable System Configuration Desktop Pro with Fast Tuning Magnetron, New Patient Support System; Important Field Safety Notice 200 01 501 038 Important Field Safety Modification 200 02 501 039 Applicable System Configuration Desktop Pro with Linac Control System MK3i, Fast Tuning Magnetron, New Patient Support System; Important Field Safety Notice 200 01 502 035 Important Field Safety Modification 200 02 502 036 Applicable System Configuration All Integrity 1.1 sites. All users of Integrity 3.1 will receive a man

    Distribution

    Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    449