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SagiPlan® with prostate module
BEBIG Medical GmbH · Model 06 · UDI-DI 04065983000047
MUJ
Prescription
1
510(k) clearances
804
Adverse events (11 deaths)
267
Recalls
57
Facilities
Description
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-20 | RAYSEARCH LABORATORIES AB | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, |
| 2026-05-20 | RAYSEARCH LABORATORIES AB | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.