Device product
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-0668-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 75718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2148
- Official record key
device-enforcement:Z-0668-2017
Official wording
Reason: Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Code information: Software Builds 5.00 and higher
Distribution pattern: Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Unite Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
Derived failure modes
-
Unknown
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.