Device product
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-1879-2016
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 74164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1401 units
- Official record key
device-enforcement:Z-1879-2016
Official wording
Reason: When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
Code information: Monaco versions 5.10.00 and higher
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
Derived failure modes
-
Unknown
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.