--- title: "Canon Medical System, USA, INC. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Canon Medical System, USA, INC. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/canon-medical-system-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Canon Medical System, USA, INC. recall records **21** reported ongoing 21 records in this archive. Latest source date Aug 4, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 4, 2026 FDA device enforcement ### [Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The s...](https://isitonrecall.com/recall/fda-device-z-3014-2026-alphenix-models-infx-8000c-infx-8000f-infx-8000v-this-device-is-a-digital-radiography-fluoroscopy-sy/) Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX. [Official source for Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3014-2026%22) Dec 19, 2025 FDA device enforcement ### [VANTAGE GALAN 3T Model MRT-3020/MEXL-3020](https://isitonrecall.com/recall/fda-device-z-1017-2026-vantage-galan-3t-model-mrt-3020-mexl-3020/) There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the heliu... Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI. [Official source for VANTAGE GALAN 3T Model MRT-3020/MEXL-3020](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1017-2026%22) Dec 19, 2025 FDA device enforcement ### [VANTAGE TITAN 3T Model MRT-3010/MEXL-3010](https://isitonrecall.com/recall/fda-device-z-1018-2026-vantage-titan-3t-model-mrt-3010-mexl-3010/) There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the heliu... Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI. [Official source for VANTAGE TITAN 3T Model MRT-3010/MEXL-3010](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1018-2026%22) Dec 19, 2025 FDA device enforcement ### [Alphenix INFX-8000C, interventional fluoroscopic x-ray system](https://isitonrecall.com/recall/fda-device-z-1176-2026-alphenix-infx-8000c-interventional-fluoroscopic-x-ray-system/) It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be po... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. [Official source for Alphenix INFX-8000C, interventional fluoroscopic x-ray system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1176-2026%22) Dec 19, 2025 FDA device enforcement ### [Alphenix INFX-8000F, interventional fluoroscopic x-ray system](https://isitonrecall.com/recall/fda-device-z-1177-2026-alphenix-infx-8000f-interventional-fluoroscopic-x-ray-system/) It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be po... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. [Official source for Alphenix INFX-8000F, interventional fluoroscopic x-ray system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1177-2026%22) Dec 19, 2025 FDA device enforcement ### [Alphenix INFX-8000H, interventional fluoroscopic x-ray system](https://isitonrecall.com/recall/fda-device-z-1178-2026-alphenix-infx-8000h-interventional-fluoroscopic-x-ray-system/) It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be po... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. [Official source for Alphenix INFX-8000H, interventional fluoroscopic x-ray system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1178-2026%22) Dec 19, 2025 FDA device enforcement ### [Alphenix INFX-8000V, interventional fluoroscopic x-ray system](https://isitonrecall.com/recall/fda-device-z-1179-2026-alphenix-infx-8000v-interventional-fluoroscopic-x-ray-system/) It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be po... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. [Official source for Alphenix INFX-8000V, interventional fluoroscopic x-ray system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1179-2026%22) Oct 16, 2025 FDA device enforcement ### [VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.](https://isitonrecall.com/recall/fda-device-z-0327-2026-vantage-galan-3t-cmsc-model-mrt-3020-u7-model-number-mexl-3020-b7/) Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. Class II Reported ongoing Distribution: US distribution to Ohio and Nevada [Official source for VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0327-2026%22) Sep 2, 2025 FDA device enforcement ### [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 angi...](https://isitonrecall.com/recall/fda-device-z-0037-2026-this-device-is-a-digital-radiography-fluoroscopy-system-used-in-a-diagnostic-and-interventional-angi/) It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the RO... Class II Reported ongoing Distribution: U.S. [Official source for This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional a...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0037-2026%22) Sep 17, 2024 FDA device enforcement ### [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 Tomogr...](https://isitonrecall.com/recall/fda-device-z-0284-2025-cartesion-prime-digital-pet-ct-model-pcd-1000a-3d-004-pcd-1000a-3d-is-a-diagnostic-imaging-system-th/) When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction m... Class II Reported ongoing Distribution: US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA [Official source for Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging s...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0284-2025%22) May 10, 2024 FDA device enforcement ### [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 M...](https://isitonrecall.com/recall/fda-device-z-2041-2024-mri-systems-vantage-orian-mrt-1550-mexl-1550-vantage-elan-mrt-2020-mexl-1520-vantage-titan-mrt-1504/) The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire. Class II Reported ongoing Distribution: US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR [Official source for MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2041-2024%22) Jan 29, 2024 FDA device enforcement ### [MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550](https://isitonrecall.com/recall/fda-device-z-1248-2024-mri-system-vantage-orian-vantage-fortian-model-mrt-1550/) For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct value... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY,... [Official source for MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1248-2024%22) Jan 29, 2024 FDA device enforcement ### [MRI system: Vantage Elan, Model: MRT-2020](https://isitonrecall.com/recall/fda-device-z-1249-2024-mri-system-vantage-elan-model-mrt-2020/) For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct value... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY,... [Official source for MRI system: Vantage Elan, Model: MRT-2020](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1249-2024%22) Jan 29, 2024 FDA device enforcement ### [Vantage Titan, Model: MRT-1504](https://isitonrecall.com/recall/fda-device-z-1250-2024-vantage-titan-model-mrt-1504/) For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct value... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY,... [Official source for Vantage Titan, Model: MRT-1504](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1250-2024%22) Nov 15, 2023 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1154-2024-the-device-is-an-x-ray-system-that-is-capable-of-radiographic-and-fluoroscopic-studies-and-is-used-i/) VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoi... Class II Reported ongoing Distribution: US: CA, LA [Official source for The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is use...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1154-2024%22) Nov 15, 2023 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-1155-2024-the-infx-8000f-is-designed-to-take-advantage-of-the-latest-technological-innovations-to-reduce-dose/) VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoi... Class II Reported ongoing Distribution: US: CA, LA [Official source for The INFX-8000F is designed to take advantage of the latest technological innovations to reduce do...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1155-2024%22) Jun 22, 2023 FDA device enforcement ### [INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE](https://isitonrecall.com/recall/fda-device-z-2392-2023-infx-8000c-xgcp-930aa-table-side-console-infx-8000c-xgcp-930ba-table-side-console/) The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switch... Class II Reported ongoing Distribution: US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA [Official source for INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2392-2023%22) Sep 29, 2022 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-0198-2023-canon-aplio-ultrasound-system-model-aplio-i900-tus-ai900-aplio-i800-tus-ai800-aplio-i700-tus-ai700-a/) After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with... Class II Reported ongoing Distribution: US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL [Official source for Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0198-2023%22) May 3, 2022 FDA device enforcement ### [System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW](https://isitonrecall.com/recall/fda-device-z-1289-2022-system-alphenix-4d-ct-in-combination-with-cas-930a-c-arm-support-model-number-infx-8000c-bf-infx-800/) CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated. Class II Reported ongoing Distribution: U.S.: CA, CO, FL, NY, and WY O.U.S.: None [Official source for System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1289-2022%22) Jan 31, 2022 FDA device enforcement ### [INFX-8000V. For radiographic and fluoroscopic studies and intervention.](https://isitonrecall.com/recall/fda-device-z-1666-2022-infx-8000v-for-radiographic-and-fluoroscopic-studies-and-intervention/) The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. Class II Reported ongoing Distribution: US Nationwide Distribution [Official source for INFX-8000V. For radiographic and fluoroscopic studies and intervention.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1666-2022%22) ## Reasons in these listed records - Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. - There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. T... - It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noi... - Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. These examples come from this result page and are not a ranking of every recall reason. ## Checking Canon Medical System, USA, INC. ### Is there a recall on canon medical system, usa, inc. right now? This archive contains 21 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Canon Medical System, USA, INC.](https://isitonrecall.com/check/?q=Canon%20Medical%20System%2C%20USA%2C%20INC.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)