Device product
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Z-0118-2013
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 63405
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 units
- Official record key
device-enforcement:Z-0118-2013
Official wording
Reason: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
Code information: None as the product is software
Distribution pattern: Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.
Derived failure modes
-
Unknown
During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.