Device product
Focal Sim radiation therapy treatment planning system
Z-1244-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 70433
- Status
- Terminated
- Classification
- Class II
- Quantity
- 907
- Official record key
device-enforcement:Z-1244-2015
Official wording
Reason: Incorrect CT to ED when using the Monaco Image Statistics Tool.
Code information: Focal Release 4.80
Distribution pattern: Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
Derived failure modes
-
Unknown
Incorrect CT to ED when using the Monaco Image Statistics Tool.