RT Desktop The EOS RT Desktop recall
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…
Why was RT Desktop The EOS RT Desktop recalled?
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
R4.2, R5.0, R5.1, R6.0, R6.1
- 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…
- Recalling firm
- Elekta, Inc.
- 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.
- Recall date
- March 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)