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Canon Medical System, USA, INC. FDA Recalls
28 recalls on file across devices, 0 of them Class I and 28 still open. Matched by name to CAJPY.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in aClass IIAug 4, 2026Due to the fixing screws of ceiling movement gear in ceiling |
| VANTAGE TITAN 3T Model MRT-3010/MEXL-3010Class IIDec 19, 2025There is a potential for formation of ice occurring in the v |
| VANTAGE GALAN 3T Model MRT-3020/MEXL-3020Class IIDec 19, 2025There is a potential for formation of ice occurring in the v |
| Alphenix INFX-8000C, interventional fluoroscopic x-ray systemClass IIDec 19, 2025It has been discovered that there is a possibility that the |
| Alphenix INFX-8000H, interventional fluoroscopic x-ray systemClass IIDec 19, 2025It has been discovered that there is a possibility that the |
| Alphenix INFX-8000F, interventional fluoroscopic x-ray systemClass IIDec 19, 2025It has been discovered that there is a possibility that the |
| Alphenix INFX-8000V, interventional fluoroscopic x-ray systemClass IIDec 19, 2025It has been discovered that there is a possibility that the |
| VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.Class IIOct 16, 2025Affected system contains components that do not meet the req |
| This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuratiClass IISep 2, 2025It has been found that when SPOT Fluoro is first turned on, |
| Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines PosClass IISep 17, 2024When PET-CT system is executing reconstruction, if PET acqui |
| MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Class IIMay 10, 2024The terminal block used to secure the power supply cable for |
| MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550Class IIJan 29, 2024For some MRI systems, it has been found that some of the max |
| Vantage Titan, Model: MRT-1504Class IIJan 29, 2024For some MRI systems, it has been found that some of the max |
| MRI system: Vantage Elan, Model: MRT-2020Class IIJan 29, 2024For some MRI systems, it has been found that some of the max |
| The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A Class IINov 15, 2023VAREX changed the manufacturing of the internal board, and t |
| The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional Class IINov 15, 2023VAREX changed the manufacturing of the internal board, and t |
| INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLEClass IIJun 22, 2023The C-arm, used to set the position and angle of the x-ray e |
| Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AClass IISep 29, 2022After completion, ultrasound system's Stress Echo may not te |
| System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INClass IIMay 3, 2022CT operation may be restricted by an interlock which is a re |
| INFX-8000V. For radiographic and fluoroscopic studies and intervention.Class IIJan 31, 2022The fluoroscopic dose rate might exceed the conforming value |
| Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-Class IIDec 20, 2021Abnormal images such as horizontal stripes may be displayed |
| Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectionaClass IIMay 21, 2021The MRI system contains a component that does not meet the a |
| Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modaClass IIMay 21, 2021The MRI system contains a component that does not meet the a |
| Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as Class IIMay 21, 2021The MRI system contains a component that does not meet the a |
| Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modalitClass IIMay 21, 2021The MRI system contains a component that does not meet the a |
| System INFX-8000VClass IIFeb 5, 2021The x-ray irradiation field may shift with respect to image |
| System INFX-8000CClass IIFeb 5, 2021The x-ray irradiation field may shift with respect to image |
| System INFX-8000FClass IIFeb 5, 2021The x-ray irradiation field may shift with respect to image |