The Recall Desk

Hazard

Radiation Dose Error recalls

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

What the numbers show

Total
12
Critical
0
Severe
2
Most recent
2025-07-09

Of the 12 radiation dose 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 2 (17%) 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 radiation dose 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.

1–12 of 12

  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    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-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2022·2022-07-20

    Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose

    Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.

    Product
    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2022·2022-07-20

    Radiography System Firmware Error May Cause Incorrect Radiation Dose

    Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.

    Product
    DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0850-2022·2022-04-06

    Medical software recall: RayStation radiation therapy dose calculation errors

    RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.

    Product
    RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0785-2021·2021-01-13

    Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

    Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2020·2020-04-01

    RayStation software recall due to virtual wedge field limitations

    RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.

    Product
    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. Aft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2017·2017-01-18

    Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations

    Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.

    Product
    Monaco RTP System 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-2567-2014·2014-09-24

    Varian C-Series Linear Accelerators Recalled for Beam Output Decrease

    Varian Medical Systems is recalling C-Series High Energy Linear Accelerators due to a trend of unexpected decreases in beam output during 6MV photon treatment.

    Product
    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2014·2014-04-09

    Elekta Integrity Software Recalled for Incorrect Radiation Beam Delivery Tolerances

    Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.

    Product
    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide