System, X-Ray, Fluoroscopic, Image-Intensified
FDA adverse event reports and recall history for system, x-ray, fluoroscopic, image-intensified (product code JAA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 90,604
- Deaths
- 20
- Injuries
- 218
- Malfunctions
- 90,159
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-09Open, ClassifiedRadiation Control for Health and Safety Act
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
- 2025-11-07Open, ClassifiedDevice Design
ProxiDiagnost N90; Model Number: 706110;
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
- 2025-11-07Open, ClassifiedDevice Design
CombiDiagnost R90; Model Number: 709031;
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
- 2025-11-07Open, ClassifiedDevice Design
Precision CRF; Model Number: 706400;
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
- 2025-06-17Open, ClassifiedDevice Design
UROSKOP Omnia. Model Number: 10094910
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- 2025-06-17Open, ClassifiedDevice Design
UROSKOP Omnia Max. Model Number: 10762473
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- 2024-11-07Open, ClassifiedSoftware change control
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
- 2024-11-07Open, ClassifiedSoftware change control
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
- 2024-08-27Open, ClassifiedDevice Design
DR 800. Digital Radiography X-ray System.
Potential for the front lever chain of the DR 800 table to fail.
- 2024-02-14Open, ClassifiedSoftware design
CombiDiagnost R90 1.0 (709030)
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
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