Device product
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-0660-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 75664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 671
- Official record key
device-enforcement:Z-0660-2017
Official wording
Reason: Incorrect Dose when using the reset function.
Code information: Software Builds 5.11 and 5.20
Distribution pattern: AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,
Derived failure modes
-
Unknown
Incorrect Dose when using the reset function.