System, X-Ray, Tomography, Computed
FDA adverse event reports and recall history for system, x-ray, tomography, computed (product code JAK), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 5,281
- Deaths
- 219
- Injuries
- 1,525
- Malfunctions
- 2,861
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-02Open, ClassifiedUnder Investigation by firm
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
- 2026-09-29Open, ClassifiedRadiation Control for Health and Safety Act
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT 530 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT 550 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT 760 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT 780 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT ATLAS with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-25Open, ClassifiedSoftware design
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- 2026-09-01Open, ClassifiedRadiation Control for Health and Safety Act
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- 2026-09-01Open, ClassifiedRadiation Control for Health and Safety Act
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
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