Hazard

Radiation Exposure recalls

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

What the numbers show

Total: 213
Critical: 0
Severe: 19
Most recent: 2026-08-05

Of the 213 radiation exposure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (9%) 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 exposure 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.

26–50 of 213

HighFDA (Devices)·Z-1583-2025·2025-04-30
Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk
Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.
Product
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1044-2025·2025-02-12
Medical X-Ray System Permits Bypass of Radiation Exposure Control
GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.
Product
Discovery XR656HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2025·2025-02-12
X-Ray Imaging System May Continue Exposure Beyond Safety Limit
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
Product
Optima XR646 HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2025·2024-12-18
Philips Allura Xper X-ray Systems Prone to Clamping Bolt Failure and Collision Risk
Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.
Product
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3158-2024·2024-10-02
Mobile X-Ray System Exposure Settings May Not Apply Correctly
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Product
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2024·2024-06-19
OMTech Desktop Laser Engraver recalled for missing safety interlocks
Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.
Product
OMTech Desktop Laser Engraver
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1603-2024·2024-05-01
Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation
IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.
Product
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2024·2023-11-08
Siemens Cios Alpha X-ray system software defect may cause patient misdiagnosis
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
Product
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2024·2023-11-08
Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
Product
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2024·2023-10-18
FDA Recalls Zemits NDPrime Yag Laser for Missing Safety Interlocks
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.
Product
MED-810A Zemits NDPrime Laser products
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2574-2023·2023-09-20
NanoDots radiation dosimeter recalled for potential measurement accuracy issues
Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.
Product
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2546-2023·2023-09-20
Medical Device: Radiation Dosimeter Units May Have Inaccurate Readings
Landauer nanoDot D2DXN radiation dosimeters may measure outside the specified +/-5.5% accuracy range due to a potential non-conformance in the optical stimulated luminescence material. Approximately 13,950 units were distributed worldwide.
Product
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2558-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for measurement inaccuracy
Landauer is recalling QC nanoDot radiation dosimeters worldwide due to potential inaccuracy in radiation dose measurements. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2542-2023·2023-09-20
Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2563-2023·2023-09-20
Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications
Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.
Product
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2548-2023·2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2562-2023·2023-09-20
Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Product
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1625-2023·2023-05-31
Incisive CT Plus imaging system recalled for potential incorrect image orientation
Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.
Product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1624-2023·2023-05-31
Incisive CT Power X-Ray System may display flipped or reversed images
The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.
Product
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1622-2023·2023-05-31
Philips CT Scanner May Display Images With Incorrect Orientation
Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.
Product
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1266-2023·2023-03-29
Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0003-2023·2022-10-12
Handheld UV-C Germicidal Wand Recalled for Excessive Radiation Exposure
IN MY BATHROOM LLC is recalling 485 units of the Seago SG-153 handheld UV-C germicidal wand nationwide due to excessive ultraviolet-C radiation. Consumers should stop using the device and contact the manufacturer for instructions.
Product
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2022·2022-09-21
Surpria 64 Software Error May Prevent Image Reconstruction During Scanning
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
Product
Surpria 64: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2022·2022-09-21
FUJIFILM Surpria Imaging Software May Fail During Scanning
Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.
Product
Surpria: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2022·2022-09-21
SCENARIA View software error may require additional patient radiation exposure
SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.
Product
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Category
Medical Device
Distribution
Distributed nationwide