Canon Medical System USA recalls

Canon Medical System USA has 50 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 2 Sep 2026. 44 are still ongoing. 9 were reported in the last 12 months.

Total recalls50since 2018

Last 12 months9reported

Class I00% of total

Ongoing44latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 1 0 2Jan '26 4 0 0Apr 0 0 0Jul 0 1

Severity split

Class I 0 0%Class II 50 100%Class III 0 0%

Why canon medical system usa is recalled

Other Reasons3162%
Device Malfunction1938%

Product types

By year

2026714%
202524%
2024714%
202312%
202248%
20211122%
20201428%
201924%
201824%

Ongoing canon medical system usa recalls

44 active

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000F, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	Vantage Titan 3t recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	Nationwide

All canon medical system usa recalls, newest first

50 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Alphenix Infx-8000F, interventional fluoroscopic x-ray system recalled	Canon Medical System USA	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	Vantage Titan 3t recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	Vantage Galan 3t recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Vantage Galan 3t recalled by Canon Medical System, USA	Canon Medical System USA	Other	NV, OH
15 Oct 2025Device	CLASS II	This device is a digital radiography/fluoroscopy system recalled	Canon Medical System USA	Device Malfunction	CA
13 Nov 2024Device	CLASS II	Cartesion Prime, Digital Pet-ct recalled by Canon Medical System, USA	Canon Medical System USA	Other	18 states
19 Jun 2024Device	CLASS II	MRI systems: Vantage Orian Mrt-1550 (Mexl-1550) recalled	Canon Medical System USA	Other	38 states
13 Mar 2024Device	CLASS II	MRI system: Vantage Orian, Vantage Fortian recalled	Canon Medical System USA	Other	Nationwide
13 Mar 2024Device	CLASS II	Vantage Titan recalled by Canon Medical System, USA	Canon Medical System USA	Other	Nationwide
13 Mar 2024Device	CLASS II	MRI system: Vantage Elan recalled by Canon Medical System, USA	Canon Medical System USA	Other	Nationwide
28 Feb 2024Device	CLASS II	The device is an X-ray system that is capable recalled	Canon Medical System USA	Device Malfunction	CA, LA
28 Feb 2024Device	CLASS II	The Infx-8000F is designed to take advantage of the latest recalled	Canon Medical System USA	Other	CA, LA
16 Aug 2023Device	CLASS II	Infx-8000c Xgcp-930aa Table Side Console recalled	Canon Medical System USA	Device Malfunction	Nationwide
16 Nov 2022Device	CLASS II	Canon Aplio ultrasound system recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	23 states
7 Sep 2022Device	CLASS II	Infx-8000V. For radiographic and fluoroscopic studies recalled	Canon Medical System USA	Other	Nationwide
6 Jul 2022Device	CLASS II	System: Alphenix 4D CT in combination with CAS-930A (C arm Support) recalled	Canon Medical System USA	Other	5 states
19 Jan 2022Device	CLASS II	Flat Panel Detector recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	Nationwide
27 Oct 2021Device	CLASS II	Canon Pet-ct Scanner, Cartesion Prime recalled	Canon Medical System USA	Device Malfunction	Nationwide
21 Jul 2021Device	CLASS II	Canon Vantage Galan 3T recalled by Canon Medical System, USA	Canon Medical System USA	Device Malfunction	Nationwide
21 Jul 2021Device	CLASS II	Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System recalled	Canon Medical System USA	Device Malfunction	Nationwide
21 Jul 2021Device	CLASS II	Toshiba Vantage Tiitan 1.5T with Standard gradient recalled	Canon Medical System USA	Device Malfunction	Nationwide
21 Jul 2021Device	CLASS II	Canon Vantage Titan 3T, Premium Open-Bore MRI System recalled	Canon Medical System USA	Device Malfunction	Nationwide
24 Mar 2021Device	CLASS II	Canon Interventional Angiography System recalled	Canon Medical System USA	Other	Nationwide
24 Mar 2021Device	CLASS II	Canon Interventional Angiography System recalled	Canon Medical System USA	Other	Nationwide
24 Mar 2021Device	CLASS II	Canon Interventional Angiography System recalled	Canon Medical System USA	Other	Nationwide
17 Mar 2021Device	CLASS II	System Infx-8000V recalled by Canon Medical System, USA	Canon Medical System USA	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.