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CORVUS 09

Best Nomos · Model 210296 · UDI-DI 00852656007410

MUJ

510(k) clearances

804

Adverse events (11 deaths)

267

Recalls

Facilities

Description

CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.

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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Data 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.