Device product
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Z-2284-2018
Product summary
- Event
- Event 80217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2284-2018
Official wording
Reason: IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Code information: PAT.003 and PAT.006
Distribution pattern: Units were distributed to Korea and Jacksonville, FL.
Derived failure modes
-
Device software or design
software issue and to reduce the risk related to this issue