FDA recall record · openFDA

Canon Medical System, USA, INC.

16 FDA recalls on record (2023–2025) — 16 device. 16 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling su 4

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "Syste 3

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI syste 2

VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of th 2

It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move t 1

Recalls

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 Class II 2025-12-19 This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configurati Class II 2025-09-02 VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Class II 2025-10-16 Alphenix INFX-8000F, interventional fluoroscopic x-ray system Class II 2025-12-19 VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 Class II 2025-12-19 Alphenix INFX-8000H, interventional fluoroscopic x-ray system Class II 2025-12-19 Alphenix INFX-8000V, interventional fluoroscopic x-ray system Class II 2025-12-19 Alphenix INFX-8000C, interventional fluoroscopic x-ray system Class II 2025-12-19 MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Class II 2024-05-10 MRI system: Vantage Elan, Model: MRT-2020 Class II 2024-01-29 Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Pos Class II 2024-09-17 Vantage Titan, Model: MRT-1504 Class II 2024-01-29 MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 Class II 2024-01-29 The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A Class II 2023-11-15 The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional Class II 2023-11-15 INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE Class II 2023-06-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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