SagiPlan 2 — Class II medical device recall Z-0517-2024
Ongoing recall by Bebig Isotopentechnik Gmbh, reported 2023-12-20. Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
| Recall number | Z-0517-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bebig Isotopentechnik Gmbh, Berlin, N/A, Germany |
| Recall initiated | 2023-10-17 |
| Classified | 2023-12-08 |
| Reported by FDA | 2023-12-20 |
| Countries outside the US | DE |
| Reason classes | device malfunction, software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0517-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.