Device product
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Z-0987-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 76085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433
- Official record key
device-enforcement:Z-0987-2017
Official wording
Reason: Cross profile for Varian 60 degree wedge shows "horns."
Code information: All software builds
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, Zambia.
Derived failure modes
-
Unknown
Cross profile for Varian 60 degree wedge shows "horns."