PlainRecalls

Canon Medical System, USA, INC.

Compiled from official public sources by the publisher.

49 recalls on record · Latest: Feb 4, 2026

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Agency notice ledger

Federal filing book Canon Medical System, USA,… MID-BOOK · SINGLE-AGENCY

#357 of 14,151 · 49 notices · 0.047% archive

  • BOOK 49 notices
  • RANK #357 of 14,151
  • SHARE 0.047% archive
  • AGENCY FDA Devices (49)
  • CAT medical devices
  • CATS 1 category
  • LATEST Feb 4, 2026
  • PHOTO Partell Specialty Pha…

Nearest notice-volume peer: Partell Specialty Pharmacy (0 notice gap)

Canon Medical System, USA, INC. accounts for about 0.047% of the 104,423-notice archive on 49 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Canon Medical System, USA,…'s standing among 14,151 recalling firms

Canon Medical System, USA, INC. ranks 357th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Canon Medical System, USA,… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

49 357th of 14151 higher than 13,790 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Canon Medical System, USA,… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Canon Medical System, USA, INC. holds about 0.047% of archive notices alongside 49 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Feb 4, 2026

Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Devices Moderate Feb 4, 2026

Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Devices Moderate Feb 4, 2026

Alphenix INFX-8000V, interventional fluoroscopic x-ray system
FDA Devices Moderate Feb 4, 2026

Alphenix INFX-8000C, 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 for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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 (PET) and X-ray Computed Tomography (CT) systems.
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 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
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 Mar 13, 2024

MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
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 interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
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 of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
FDA Devices Moderate Aug 16, 2023

INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
FDA Devices Moderate Nov 16, 2022

Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
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 Jul 21, 2021

Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
FDA Devices Moderate Jul 21, 2021

Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
FDA Devices Moderate Jul 21, 2021

Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
FDA Devices Moderate Jul 21, 2021

Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
FDA Devices Moderate Mar 24, 2021

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
FDA Devices Moderate Mar 24, 2021

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
FDA Devices Moderate Mar 24, 2021

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
FDA Devices Moderate Mar 17, 2021

System INFX-8000C
FDA Devices Moderate Mar 17, 2021

System INFX-8000F
FDA Devices Moderate Mar 17, 2021

System INFX-8000V
FDA Devices Moderate Dec 16, 2020

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
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-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
FDA Devices Moderate Sep 2, 2020

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
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 diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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 diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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 diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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 Apr 22, 2020

Canon Aquilion One, Model TSX-301A
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 (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
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 system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image
FDA Devices Moderate Oct 31, 2018

Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
FDA Devices Moderate Sep 12, 2018

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Canon Medical System, USA,… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Canon Medical System, USA,…? ▼
PlainRecalls indexes 49 distinct federal recall events naming Canon Medical System, USA, INC., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Canon Medical System, USA,… sit among other recalling firms? ▼
Canon Medical System, USA, INC. ranks #357 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Canon Medical System, USA,…'s notices? ▼
FDA Devices accounts for 49 of this firm's 49 indexed notices.
What product category dominates Canon Medical System, USA,…'s filing book? ▼
Filings for Canon Medical System, USA, INC. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Canon Medical System, USA, INC.: 49 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Canon Medical System, USA, INC.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026