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Recall Observatory FDA recall evidence

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

November 25, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.