Hazard

Dose Calculation Error recalls

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

What the numbers show

Total: 51
Critical: 0
Severe: 6
Most recent: 2025-02-26

Of the 51 dose calculation 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 6 (12%) 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 dose calculation 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.

1–25 of 51

HighFDA (Devices)·Z-1195-2025·2025-02-26
RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency
RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1189-2025·2025-02-26
Radiation Therapy Planning System Density Calculation Inconsistency in RayStation
RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1192-2025·2025-02-26
RayStation radiation therapy planning software density uncertainty computational defect
RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2025·2025-02-26
RayStation radiation therapy planning software density uncertainty calculation inconsistency
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1194-2025·2025-02-26
Medical device recall: RayStation radiation therapy software dose calculation inconsistency
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Category
Medical Device
Distribution
Distributed nationwide
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-1191-2025·2025-02-26
RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2025·2025-02-26
RayStation radiation therapy planning software density uncertainty calculation inconsistency
RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in density uncertainty handling when HU-to-mass density CT calibration curves are used. No illnesses or injuries have been reported.
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2024·2024-05-08
Radiation therapy planning system doses may be calculated incorrectly
Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.
Product
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2024·2024-05-08
Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly
RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.
Product
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2024·2024-05-08
Radiation therapy planning system may calculate patient doses too high
RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.
Product
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2024·2024-05-08
Radiation therapy planning system dose calculation error
RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.
Product
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2024·2024-05-08
RayStation radiation therapy planning software affected by source-to-surface distance calculation error
RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.
Product
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2024·2024-05-08
RayStation radiation therapy system dosing parameter recall
RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.
Product
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1751-2024·2024-05-08
RayStation radiation therapy planning system may report inaccurate dosimetry values
RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.
Product
RayStation 14.0.0.3338. 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-1482-2024·2024-04-17
RayStation Software Use Error Could Cause Incorrect Radiation Dose Calculations
RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.
Product
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2022·2022-07-06
Radiation therapy software shows misleading dose display in RayStation 11B
RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.
Product
RayStation 11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2022·2022-04-06
Radiation therapy planning software: incorrect dose density calculation
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0182-2022·2021-11-03
Brachytherapy Planning Software Dose Calculation Discrepancy
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
Product
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1597-2021·2021-05-26
RayStation Software Recall Due to Dose Labeling Error in Merged Beams
RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.
Product
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2340-2020·2020-06-17
RayStation 5 Service Pack 3 Radiation Therapy Software Recalled
RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.
Product
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2342-2020·2020-06-17
RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2348-2020·2020-06-17
RayStation 8B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.
Product
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2349-2020·2020-06-17
RayStation 9A Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.
Product
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide