FDA Device recall Z-0517-2024
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System by Bebig Isotopentechnik, citing due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0517-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-17 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bebig Isotopentechnik |
| Distribution | MD |
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.
Identifiers
| code_info | SagiPlan, article # 1374-0600, version 2.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0517-2024%22
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