RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended...
FDA Recall #Z-1081-2014 — Class II — November 25, 2013
Product Description
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.
Reason for Recall
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Recalling Firm
Elekta, Inc. — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
489
Distribution
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.
Code Information
R4.2, R5.0, R5.1, R6.0, R6.1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.