Recall archive / FDA device enforcement
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System — FDA record Z-0517-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- Reason
- Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
- Classification
- Class II
- Recalling firm
- Bebig Isotopentechnik Gmbh
- Quantity
- 2 software licenses in US, 255 software licenses in OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0517-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | SagiPlan, article # 1374-0600, version 2.2 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MD OUS: Germany
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 20, 2023
- Recall initiation date
- Oct 17, 2023
- Center classification date
- Dec 8, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.