FDA recall Z-0517-2024
Bebig Isotopentechnik Gmbh · Class II · device
Product
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Reason for recall
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Distribution
US: MD OUS: Germany
Key facts
- Status
- Ongoing
- Initiation date
- 2023-10-17
- Report date
- 2023-12-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Berlin, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0517-2024