Canon Medical System, USA, INC.

Complete recall history across all FDA and CPSC categories — 49 total recalls

Canon Medical System, USA, INC. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (49)

FDA medical device enforcement actions by Canon Medical System, USA, INC.

Date Product Reason Class
Dec 19, 2025 Alphenix INFX-8000C, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of ... Class II
Dec 19, 2025 Alphenix INFX-8000V, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of ... Class II
Dec 19, 2025 Alphenix INFX-8000H, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of ... Class II
Dec 19, 2025 VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 There is a potential for formation of ice occurring in the venting system of ... Class II
Dec 19, 2025 Alphenix INFX-8000F, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of ... Class II
Dec 19, 2025 VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 There is a potential for formation of ice occurring in the venting system of ... Class II
Oct 16, 2025 VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Affected system contains components that do not meet the required distance be... Class II
Sep 2, 2025 This device is a digital radiography/fluoroscopy system used in a diagnostic ... It has been found that when SPOT Fluoro is first turned on, the default ROI i... Class II
Sep 17, 2024 Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a ... When PET-CT system is executing reconstruction, if PET acquisition for anothe... Class II
May 10, 2024 MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-... The terminal block used to secure the power supply cable for the gradient coi... Class II
Jan 29, 2024 MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 For some MRI systems, it has been found that some of the maximum Spatial Fiel... Class II
Jan 29, 2024 Vantage Titan, Model: MRT-1504 For some MRI systems, it has been found that some of the maximum Spatial Fiel... Class II
Jan 29, 2024 MRI system: Vantage Elan, Model: MRT-2020 For some MRI systems, it has been found that some of the maximum Spatial Fiel... Class II
Nov 15, 2023 The device is an X-ray system that is capable of radiographic and fluoroscopi... VAREX changed the manufacturing of the internal board, and the detectors disp... Class II
Nov 15, 2023 The INFX-8000F is designed to take advantage of the latest technological inno... VAREX changed the manufacturing of the internal board, and the detectors disp... Class II
Jun 22, 2023 INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C... The C-arm, used to set the position and angle of the x-ray exposure field, ma... Class II
Sep 29, 2022 Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI... After completion, ultrasound system's Stress Echo may not terminate if user d... Class II
May 3, 2022 System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model ... CT operation may be restricted by an interlock which is a result of an system... Class II
Jan 31, 2022 INFX-8000V. For radiographic and fluoroscopic studies and intervention. The fluoroscopic dose rate might exceed the conforming value during biplane f... Class II
Dec 20, 2021 Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, ... Abnormal images such as horizontal stripes may be displayed and recovery may ... Class II
May 21, 2021 Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic im... The MRI system contains a component that does not meet the appropriate flame... Class II
May 21, 2021 Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Prod... The MRI system contains a component that does not meet the appropriate flame... Class II
May 21, 2021 Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI Sys... The MRI system contains a component that does not meet the appropriate flame... Class II
May 21, 2021 Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product... The MRI system contains a component that does not meet the appropriate flame... Class II
Feb 5, 2021 System INFX-8000V The x-ray irradiation field may shift with respect to image receiving surface... Class II
Feb 5, 2021 System INFX-8000F The x-ray irradiation field may shift with respect to image receiving surface... Class II
Feb 5, 2021 System INFX-8000C The x-ray irradiation field may shift with respect to image receiving surface... Class II
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization ... System table may tilt because the bolts that fasten the vertical column and t... Class II
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization T... System table may tilt because the bolts that fasten the vertical column and t... Class II
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization T... System table may tilt because the bolts that fasten the vertical column and t... Class II
Nov 11, 2020 Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A A software problem has been identified which could result in the diagnostic i... Class II
Nov 9, 2020 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product... A software problem has been identified which could result in the CT Scanner ... Class II
Oct 8, 2020 CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interven... There is a potential that the cable of the Flat panel detector may break duri... Class II
Jul 8, 2020 System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Pr... During a procedure, when images were acquired, and these images were transfer... Class II
Mar 3, 2020 Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage... Bolts holding the longitudinal movement of catheterization tables may be loos... Class II
Mar 3, 2020 Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage... Bolts holding the longitudinal movement of catheterization tables may be loos... Class II
Mar 3, 2020 Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage... Bolts holding the longitudinal movement of catheterization tables may be loos... Class II
Mar 25, 2019 Canon Aquilion One, Model TSX-301A Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion Premium, Model TSX-301B Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion One Vision, Model TSX-301C Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion Precision, Model TSX-304A Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion Lightning, Model TSX-036A Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion Prime, Model TSX-303A Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion Prime SP, Model TSX-303B Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Mar 25, 2019 Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 Scanning may be interrupted due to an error during execution of the eXam Plan... Class II
Feb 8, 2019 Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Produ... Table tilts without operator involvement as a result of liquid spilling into ... Class II
Oct 16, 2018 Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... software malfunction; It was found when a user performs radiography using th... Class II
May 30, 2018 Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a di... When using respiratory gating with Steady Mode ON in Spin Echo sequence scann... Class II
Apr 18, 2018 DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) It was found when an operator performs a radiography using the wireless flat ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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