Canon Medical System, USA, INC.
31 recalls on record · Latest: Feb 4, 2026
FDA Devices Moderate Feb 4, 2026
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Devices Moderate Jan 21, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
FDA Devices Moderate Jan 21, 2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
FDA Devices Moderate Nov 5, 2025
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
FDA Devices Moderate Oct 15, 2025
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated f…
FDA Devices Moderate Nov 13, 2024
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PE…
FDA Devices Moderate Jun 19, 2024
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (ME…
FDA Devices Moderate Mar 13, 2024
MRI system: Vantage Elan, Model: MRT-2020
FDA Devices Moderate Mar 13, 2024
Vantage Titan, Model: MRT-1504
FDA Devices Moderate Feb 28, 2024
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user in…
FDA Devices Moderate Feb 28, 2024
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists …
FDA Devices Moderate Sep 7, 2022
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
FDA Devices Moderate Jul 6, 2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
FDA Devices Moderate Jan 19, 2022
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
FDA Devices Moderate Oct 27, 2021
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
FDA Devices Moderate Mar 17, 2021
System INFX-8000C
FDA Devices Moderate Mar 17, 2021
System INFX-8000F
FDA Devices Moderate Dec 9, 2020
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000…
FDA Devices Moderate Jun 17, 2020
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
FDA Devices Moderate Jun 17, 2020
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
FDA Devices Moderate Jun 17, 2020
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
FDA Devices Moderate Apr 22, 2020
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
FDA Devices Moderate Apr 22, 2020
Canon Aquilion Prime SP, Model TSX-303B
FDA Devices Moderate Apr 22, 2020
Canon Aquilion Prime, Model TSX-303A
FDA Devices Moderate Apr 22, 2020
Canon Aquilion Lightning, Model TSX-036A
FDA Devices Moderate Apr 22, 2020
Canon Aquilion Precision, Model TSX-304A
FDA Devices Moderate Apr 22, 2020
Canon Aquilion One Vision, Model TSX-301C
FDA Devices Moderate Apr 22, 2020
Canon Aquilion Premium, Model TSX-301B
FDA Devices Moderate Nov 20, 2019
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (I…
FDA Devices Moderate Jul 17, 2019
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray …
FDA Devices Moderate Sep 12, 2018