System, X-Ray, Stationary
FDA adverse event reports and recall history for system, x-ray, stationary (product code KPR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,217
- Deaths
- 5
- Injuries
- 151
- Malfunctions
- 947
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
- 2026-02-05Open, ClassifiedProcess control
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
- 2025-11-07Open, ClassifiedDevice Design
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
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
Radiography 7300 C; Model Number: 712037;
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.
- 2025-10-07Open, ClassifiedDevice Design
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
- 2025-04-11Open, ClassifiedUnder Investigation by firm
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Potential for collimator to fall as a result of incorrect installation.
- 2025-04-11Open, ClassifiedUnder Investigation by firm
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Potential for collimator to fall as a result of incorrect installation.
- 2025-02-03Open, ClassifiedRadiation Control for Health and Safety Act
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
- 2025-02-03Open, ClassifiedRadiation Control for Health and Safety Act
Discovery XR656HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
- 2025-02-03Open, ClassifiedRadiation Control for Health and Safety Act
Discovery XR656 HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
- 2025-02-03Open, ClassifiedRadiation Control for Health and Safety Act
Optima XR646 HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Monitor system, x-ray, stationary automatically
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