FDA Enforcement
Class II
Ongoing
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Recall: Z-0517-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0517-2024
- Event ID
- 93399
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Bebig Isotopentechnik Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 20, 2023
- Initiation Date
- October 17, 2023
- Classification Date
- December 8, 2023
- Address
- Robert-Rossle-Str. 10, N/A, Berlin, N/A, N/A, Germany
Description
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Reason
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Code Info
SagiPlan, article # 1374-0600, version 2.2
Distribution
US: MD OUS: Germany
Quantity
2 software licenses in US, 255 software licenses in OUS