The Recall Desk

Hazard

Treatment Planning Error recalls

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

What the numbers show

Total
18
Critical
0
Severe
0
Most recent
2025-02-26

Of the 18 treatment planning error 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.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all treatment planning error 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.

1–18 of 18

  • HighFDA (Devices)·Z-1185-2025·2025-02-26

    Radiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.

    Product
    Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2025·2025-02-26

    Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning

    RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3127-2024·2024-09-18

    Proton Therapy System May Display Insufficient Images During Treatment Planning

    FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2024·2024-05-08

    RayStation Radiation Therapy Planning Software Recalled for Calculation Error

    RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.

    Product
    RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2024·2024-05-08

    RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error

    RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.

    Product
    RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2024·2024-05-08

    Radiation Therapy Planning System May Report Dose Values Too High

    RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.

    Product
    RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2024·2024-01-24

    GammaPod Radiation Treatment Planning System Software Error Allows Wrong Imaging Structures

    Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.

    Product
    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2024·2023-11-22

    Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning

    A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.

    Product
    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2024·2023-11-22

    Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning

    Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.

    Product
    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2023·2023-07-05

    RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

    RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

    Product
    Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1233-2023·2023-03-15

    Monaco RTP System software may calculate radiation therapy doses inaccurately

    Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2022·2022-04-06

    Radiation therapy planning software subject to jaw positioning errors during optimization

    RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.

    Product
    TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2022·2022-01-19

    Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors

    PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.

    Product
    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2022·2021-12-22

    Activforce 2 force measurement device recalled for inaccurate measurement

    Activforce 2 medical devices (145 units) are being recalled due to a manufacturing defect causing inaccurate force measurement, which may lead to incorrect treatment planning. Verify your device's serial number against the FDA recall list.

    Product
    activforce 2 package labeling: Model: Activ5-M R 201-200563
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2563-2021·2021-10-06

    Radiation therapy planning software can save contours to wrong image set

    Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.

    Product
    Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2021·2021-09-22

    Siemens radiation therapy software may lose treatment structure data

    Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.

    Product
    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2019·2019-05-29

    Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation

    Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.

    Product
    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide