System, Planning, Radiation Therapy Treatment
Radiology · 21 CFR 892.5050
Recent MDR events
804 adverse event reports on file
- PLANONE 1Jul 15, 2026MalfunctionCosylab, Jsc, Control System Laboratory3014425747-2026-00001
- MONACOJun 2, 2026MalfunctionElekta Solutions Ab3015232217-2026-00016
- RAYCAREMay 22, 2026MalfunctionRaysearch Laboratories Ab (publ)3010034862-2026-00002
- RAYCAREMay 22, 2026MalfunctionRaysearch Laboratories Ab (publ)3007774465-2026-00002
- RAYCAREMay 19, 2026MalfunctionRaysearch Laboratories Ab (publ)3007774465-2026-00001
- RAYCAREMay 19, 2026MalfunctionRaysearch Laboratories Ab (publ)3010034862-2026-00001
- MONACOApr 23, 2026MalfunctionElekta Solutions Ab3015232217-2026-00010
- LEKSELL GAMMAPLANDec 23, 2025MalfunctionElekta Solutions Ab3015232217-2025-00063
- RAYSTATIONNov 27, 2025MalfunctionRaysearch Laboratories Ab (publ)3007774465-2025-00003
- RAYSTATIONNov 27, 2025MalfunctionRaysearch Laboratories Ab (publ)3010034862-2025-00003
Event type breakdown
Recalls
267 recall events for this product code
- RAYSEARCH LABORATORIES ABOpen, ClassifiedJul 1, 2026
RayCare 2024A SP1. Oncology Information Systems.
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, the user is not notified of the change.
Z-2646-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJul 1, 2026
RayCare 2024A SP4. Oncology Information Systems.
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, the user is not notified of the change.
Z-2647-2026 · View FDA record ↗ - Elekta, Inc.Open, ClassifiedFeb 10, 2026
Brand Name: Leksell GammaPlan
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 treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Z-1339-2026 · View FDA record ↗ - Elekta, Inc.Open, ClassifiedFeb 10, 2026
Brand Name: Leksell GammaPlan
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 treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Z-1340-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
RayStation/RayPlan. Model/Catalog Number: 10.1.
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1102-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4.
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1103-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0.
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1104-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
Brand Name: RayStation
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1105-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
Brand Name: RayStation
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1106-2026 · View FDA record ↗ - RAYSEARCH LABORATORIES ABOpen, ClassifiedJan 16, 2026
Brand Name: RayStation
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Z-1107-2026 · View FDA record ↗
Registered firms
169 firms currently registered for this product code
Reflexion Medical, Inc.
Hayward, CA, US
Prowess, Inc.
Concord, CA, US
Ge Healthcare
Chicago, IL, US
Philips Medical Systems (cleveland), Inc.
Gainesville, FL, US
Elekta Solutions Ab
STOCKHOLM, SE
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Philips Electronics Ltd
Mississauga Ontario, CA
Varian Medical Systems Finland 0y
Helsinki Uusimaa, FI
Varian Medical Systems Imaging Laboratory Gmbh
Daettwil, Argovia Aargau, CH
Diversilabs
Jim Thorpe, PA, US
Linatech, Llc
Sunnyvale, CA, US
Raysearch Laboratories Ab (publ)
Stockholm, SE
The University Of Texas Md Anderson Cancer Center, Department Of Radiation Physics, Division Of Radiation Oncology
Houston, TX, US
Raysearch Americas Inc.
Manhattan, NY, US
Lifeline Software, Inc.
Tyler, TX, US
Therapanacea
Paris, FR
Siemens Healthineers Ag Varian Cancer Therapy (cth)
Erlangen Bavaria, DE
510(k) clearances
257 clearances for this product code
- Varian Medical Systems, Inc.Jul 8, 2026
K260750 · Virtual Cone (1.0)
- InformaiJun 18, 2026
K253050 · RadOncAI
- Philips Medical Systems Nederland B.V.May 27, 2026
K260207 · Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- Anatomical Geometry S.L.May 22, 2026
K252784 · eXaSkin Plus
- Seetreat Pty, Ltd.May 14, 2026
K253078 · ART.1-US
- Varian Medical Systems, Inc.Mar 18, 2026
K252304 · syngo.via RT Image Suite VC10
- Adaptiiv Medical Technologies, Inc.Feb 19, 2026
K260308 · TrueFit Bolus
- Elekta Solutions ABFeb 19, 2026
K252002 · Monaco RTP System (6.3)