Device product
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Z-1237-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 70434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1354
- Official record key
device-enforcement:Z-1237-2015
Official wording
Reason: Incorrect CT to ED when using the Monaco Image Statistics Tool.
Code information: Monaco Release 3.30 and higher
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.
Derived failure modes
-
Unknown
Incorrect CT to ED when using the Monaco Image Statistics Tool.