Brand

Canon Medical System, Usa, Inc. Recalls

31 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Canon Medical System, Usa, Inc..

31Total Recalls
1Critical
1,227Units Affected
Dec 19, 2025Most Recent
All Recalls

Every Canon Medical System, Usa, Inc. Recall

Sorted by most recent. Click any recall for full details.

31 recalls
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Medical Devices·34 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Medical Devices·98 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Medical Devices·22 affected·Dec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Medical Devices·2 affected·Oct 16, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is...
Cardiac Devices·8 affected·Sep 2, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission To...
Diagnostic Devices·27 affected·Sep 17, 2024
CriticalFDA
Canon Medical System, Usa, Inc.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T ...
Medical Devices·153 affected·May 10, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
MRI system: Vantage Elan, Model: MRT-2020
Medical Devices·1 affected·Jan 29, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
Vantage Titan, Model: MRT-1504
Medical Devices·40 affected·Jan 29, 2024
High RiskFDA
Canon Medical System, Usa, Inc.
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary gra...
Medical Devices·2 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The syst...
Medical Devices·1 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Medical Devices·6 affected·May 3, 2022
High RiskFDA
Canon Medical System, Usa, Inc.
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Medical Devices·16 affected·Jan 31, 2022
High RiskFDA
Canon Medical System, Usa, Inc.
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8...
Medical Devices·8 affected·Dec 20, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000C
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000F
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Medical Devices·3 affected·Nov 11, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and ...
Cardiac Devices·14 affected·Oct 8, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·15 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·46 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·24 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Medical Devices·35 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion Prime SP, Model TSX-303B
Medical Devices·10 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion Prime, Model TSX-303A
Medical Devices·10 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion Lightning, Model TSX-036A
Medical Devices·6 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion Precision, Model TSX-304A
Medical Devices·1 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion One Vision, Model TSX-301C
Medical Devices·1 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Canon Aquilion Premium, Model TSX-301B
Medical Devices·2 affected·Mar 25, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-800...
Surgical Devices·9 affected·Feb 8, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general pu...
Medical Devices·46 affected·Oct 16, 2018
High RiskFDA
Canon Medical System, Usa, Inc.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Medical Devices·43 affected·Apr 18, 2018