PlainRecalls

Canon Medical System, USA, INC.

31 recalls on record · Latest: Feb 4, 2026

Canon Medical System, USA, INC. Recall Insight

Canon Medical System, USA, INC. appears on 31 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.037% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 4, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 31 entries, severity tagging shows 0 critical, 31 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 31 of 31 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (31). The date window on this page runs from Sep 12, 2018 to Feb 4, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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

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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Canon Medical System, USA, INC. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds