Device product
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Z-1492-2014
Product summary
- Event
- Event 67678
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-1492-2014
Official wording
Reason: Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
Code information: Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
Distribution pattern: US Distribution including the states of OK, IL, NJ, and WA.
Derived failure modes
-
Unknown
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).