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RayStation
Raysearch Laboratories AB (Publ) · Model 12A · UDI-DI 07350002010549
MUJ
Prescription
1
510(k) clearances
804
Adverse events (11 deaths)
267
Recalls
57
Facilities
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.