Drug recall
SagiPlan 2.2, CE0344, Rx Only, Brachyterapy Treatment Planning System
FDA recall event 93399 · Class II · Bebig Isotopentechnik Gmbh
Key facts
| Event ID | 93399 |
|---|---|
| Recall numbers | Z-0517-2024 |
| Recalling firm | Bebig Isotopentechnik Gmbh |
| Product type | Devices |
| Products | SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. |
| Initiation date | Oct 17, 2023 |
| Report date | Dec 20, 2023 |
| City | Berlin |
| Country | Germany |
| FEI number | 1000310011 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: