Device product
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Z-1712-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 71318
- Status
- Terminated
- Classification
- Class II
- Quantity
- 351
- Official record key
device-enforcement:Z-1712-2015
Official wording
Reason: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Code information: MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3
Distribution pattern: AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia
Derived failure modes
-
Unknown
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.