Canon Medical System, Usa, Inc.
Tustin, CA
This page shows every FDA and USDA recall linked to Canon Medical System, Usa, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
49
Total Recalls
2018
First Recall
2026
Most Recent
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Jan 27, 2026
· Device
Open, Classified
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Jan 27, 2026
· Device
Open, Classified
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Jan 27, 2026
· Device
Open, Classified
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Jan 27, 2026
· Device
Open, Classified
VANTAGE TITAN 3T
Model MRT-3010/MEXL-3010
Jan 13, 2026
· Device
Open, Classified
VANTAGE GALAN 3T
Model MRT-3020/MEXL-3020
Jan 13, 2026
· Device
Open, Classified
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Oct 24, 2025
· Device
Open, Classified
This device is a digital radiography/fluoroscopy system used in a diagnostic
and interventional angiography co...
Oct 8, 2025
· Device
Open, Classified
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that co...
Nov 1, 2024
· Device
Open, Classified
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (ME...
Jun 9, 2024
· Device
Open, Classified
MRI system: Vantage Elan, Model: MRT-2020
Mar 4, 2024
· Device
Open, Classified
Vantage Titan, Model: MRT-1504
Mar 4, 2024
· Device
Open, Classified
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Mar 4, 2024
· Device
Open, Classified
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to sav...
Feb 16, 2024
· Device
Open, Classified
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an inter...
Feb 16, 2024
· Device
Open, Classified
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE,
INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Aug 11, 2023
· Device
Open, Classified
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio...
Nov 8, 2022
· Device
Open, Classified
System: Alphenix 4D CT in combination with CAS-930A (C arm Support)
Model Number:
INFX-8000C/BF,
INFX-8000C/B...
Jun 24, 2022
· Device
Open, Classified
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Jan 31, 2022
· Device
Open, Classified
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-80...
Dec 20, 2021
· Device
Open, Classified
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic im...
May 21, 2021
· Device
Open, Classified
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usag...
May 21, 2021
· Device
Open, Classified
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imagi...
May 21, 2021
· Device
Open, Classified
Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cros...
May 21, 2021
· Device
Open, Classified
System INFX-8000F
Feb 5, 2021
· Device
Open, Classified
System INFX-8000C
Feb 5, 2021
· Device
Open, Classified
System INFX-8000V
Feb 5, 2021
· Device
Open, Classified
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F
Catheterization Table CAT-880B
Canon CATHETERIZAT...
Dec 8, 2020
· Device
Open, Classified
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Catheterization Table CAT-880B
Canon CATHETERIZA...
Dec 8, 2020
· Device
Open, Classified
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C
Catheterization Table CAT-880B
Canon CATHETERIZAT...
Dec 8, 2020
· Device
Open, Classified
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Nov 11, 2020
· Device
Terminated
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and d...
Nov 9, 2020
· Device
Terminated
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model...
Oct 8, 2020
· Device
Terminated
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Jul 8, 2020
· Device
Open, Classified
Canon Aquilion Prime SP, Model TSX-303B
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion One, Model TSX-301A
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion One Vision, Model TSX-301C
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion Premium, Model TSX-301B
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion Lightning, Model TSX-036A
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion Prime, Model TSX-303A
Apr 10, 2020
· Device
Open, Classified
Canon Aquilion Precision, Model TSX-304A
Apr 10, 2020
· Device
Open, Classified
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiog...
Mar 3, 2020
· Device
Open, Classified
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiog...
Mar 3, 2020
· Device
Open, Classified
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiog...
Mar 3, 2020
· Device
Open, Classified
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization tab...
Feb 8, 2019
· Device
Terminated
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005
Product Usage:
The...
Oct 16, 2018
· Device
Terminated
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that pr...
May 30, 2018
· Device
Open, Classified
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Apr 18, 2018
· Device
Terminated