FDAFDA · Food and drugs·Recall number Z-1081-2014
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.
Published March 12, 2014 · Recall initiated: November 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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.
- Lot
- R4.2, R5.0, R5.1, R6.0, R6.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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