Device product
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Z-0479-2022
Product summary
- Event
- Event 89314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0479-2022
Official wording
Reason: When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Code information: S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust
Distribution pattern: US Nationwide distribution in the state of CO.
Derived failure modes
-
Device software or design
software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error