The Recall Desk

Hazard

Radiotherapy recalls

15 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2026-06-17

Of the 15 radiotherapy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all radiotherapy recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–15 of 15

  • HighFDA (Devices)·Z-2406-2026·2026-06-17

    MOSAIQ oncology software may fail to load adapted treatment plan

    The MOSAIQ Oncology Information System is being recalled because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2026·2026-02-18

    GammaPlan software recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan versions 11.3 and 11.4 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2026·2026-02-04

    Linear accelerators recalled over a manufacturing and electrical grounding issue

    Elekta is recalling 5,391 medical linear accelerators, covering Elekta Synergy, Harmony, Infinity and Versa HD, due to a manufacturing issue and electrical grounding of systems.

    Product
    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1108-2026·2026-01-28

    RayStation 2024A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 15.2.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1104-2026·2026-01-28

    RayStation 11B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 12.0.0, 12.1.0, 12.0.3, 12.0.4 and 12.3.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1157-2026·2026-01-28

    RayStation 10B SP1 recalled over radiation dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    SQ40S Blood Transfusion Filter
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1105-2026·2026-01-28

    RayStation 12A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 13.0.0.1547, 13.1.0.144 and 13.1.1.89 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1109-2026·2026-01-28

    RayStation 2024B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1106-2026·2026-01-28

    RayStation 2023B and 2024A recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 14.0.0, 15.0.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1103-2026·2026-01-28

    RayStation 11A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 11.0.0, 11.0.1, 11.0.3 and 11.0.4 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0415-2026·2026-01-28

    RayStation 10B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1110-2026·2026-01-28

    RayStation v2025 treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 17.0.0 and 17.0.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1078-2026·2026-01-21

    Oncology information system recalled over a potential for overtreatment

    Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.

    Product
    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    Radiotherapy systems recalled over software allowing more than two daily fractions

    RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
    Category
    Medical Device
    Distribution
    Distributed nationwide