Device product
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Z-1081-2014
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 67217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 489
- Official record key
device-enforcement:Z-1081-2014
Official wording
Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Code information: R4.2, R5.0, R5.1, R6.0, R6.1
Distribution pattern: Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.
Derived failure modes
-
Unknown
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.