Device product
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Z-0517-2024
Product summary
- Event
- Event 93399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 software licenses in US, 255 software licenses in OUS
- Official record key
device-enforcement:Z-0517-2024
Official wording
Reason: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Code information: SagiPlan, article # 1374-0600, version 2.2
Distribution pattern: US: MD OUS: Germany
Derived failure modes
-
Device software or design
software malfunction