Canon Medical System, USA, INC. recalls
Every recall we track for Canon Medical System, USA, INC. — 51 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Canon Medical System, USA, INC. peaked in 2020 (10); 51 since 2017. 4% rated “stop using now”.
All FDA recall records for Canon Medical System, USA, INC. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 1 | 2 | 0 | 3 |
| 2019 | 0 | 1 | 8 | 0 | 9 |
| 2020 | 0 | 7 | 3 | 0 | 10 |
| 2021 | 1 | 4 | 3 | 0 | 8 |
| 2022 | 0 | 1 | 2 | 0 | 3 |
| 2023 | 0 | 2 | 1 | 0 | 3 |
| 2024 | 1 | 0 | 4 | 0 | 5 |
| 2025 | 0 | 3 | 4 | 1 | 8 |
| 2026 (to date) | 0 | 2 | 0 | 0 | 2 |
What to do if you have a recalled Canon Medical System, USA, INC. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Canon Medical System, USA, INC. recalls
28 shown- Use cautionMedical device
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Canon Medical recalls one Alphenix INFX-8000C/B5 device (serial B5F2532011/UDI 4987670100192) due to risk of tabletop shifting causing imaging errors. Stop using immediately.
Canon MedicalAug 26, 2026 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a
Canon Medical recalls Alphenix INFX-8000C/F/V models due to potential loose fixing screws in ceiling suspension that could cause equipment failure during procedures.
Canon MedicalAug 4, 2026 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Canon recalls Alphenix INFX-8000F interventional fluoroscopy systems due to potential loose ceiling screws causing movement issues and sensor errors. Affected units have specific serial numbers listed in the recall.
CanonDec 19, 2025 - Use cautionMedical device
Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical recalls Vantage Galan 3T MRI systems (MRT-3020/MEXL-3020 models) due to potential ice formation in the magnet's venting system that could cause helium vessel rupture if a quench occurs.
Canon MedicalDec 19, 2025 - UnratedMedical device
Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Canon Medical recalls Vantage Galan 3T MRI systems with model MRT-3020/U7 and MEXL-3020/B7 due to potential electrode distance issues violating medical safety standards. Affected units may not meet IEC 60601-1 compliance.
Canon MedicalOct 16, 2025 - Lower riskMedical device
Canon Medical System, USA, INC. recalls This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography
Canon Medical recalls SPOT Fluoro digital radiography systems with specific serial numbers due to potential X-ray coverage issues when changing acquisition programs. Affected units may have partial X-ray coverage risks during certain operations.
Canon MedicalSep 2, 2025 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines
Canon Medical recalls specific models of Cartesion Prime PET-CT scanners due to potential PET reconstruction hangs during scans, requiring repeat exams. Affected units include PCD-1000A/3D.004 and PCD-1000A/3D models with serial numbers starting with 3DA20.
Canon MedicalSep 17, 2024 - Stop using nowMedical device
Canon Medical System, USA, INC. recalls MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),
Canon Medical recalls Vantage Orian, Elan, Titan and Galan MRI systems due to potential fire hazard from cable disconnection. Affected models include MRT-1550, MRT-2020, MRT-1504 and MRT-3010/3020 with specific serial numbers.
Canon MedicalMay 10, 2024 - Lower riskMedical device
Canon Medical System, USA, INC. recalls MRI system: Vantage Elan, Model: MRT-2020
Canon Medical recalls Vantage Elan MRI systems (Model MRT-2020) due to potential incorrect safety settings that may cause discomfort for patients with MR conditional devices during scans.
Canon MedicalJan 29, 2024 - Use cautionMedical device
Canon Medical System, USA, INC. recalls The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A
Canon Medical recalls INFX-8000F X-ray systems that may display horizontal stripes causing incomplete exams or requiring re-scans. Affected units have specific UDI-DI and serial numbers.
Canon MedicalNov 15, 2023 - Use cautionMedical device
Canon Medical System, USA, INC. recalls INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Canon Medical recalls INFX-8000C XGCP-930AA and XGCP-930BA table side consoles due to potential c-arm malfunction. The console's PWB may need replacement to prevent procedure delays.
Canon MedicalJun 22, 2023 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550
Canon recalls Aplio i900, i800, i700, and a550 ultrasound systems with software versions V4.6-V6.5 that may display incorrect images during patient exams, causing treatment delays.
CanonSep 29, 2022 - Use cautionMedical device
Canon Medical System, USA, INC. recalls System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH,
Canon Medical recalls Alphenix 4D CT systems with specific model numbers and C arm supports due to potential system errors causing CT operations to stop after error messages are canceled.
Canon MedicalMay 3, 2022 - Lower riskMedical device
Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Canon recalls INFX-8000V fluoroscopy systems for potential dose rate exceedance during biplane procedures. Affected units include Alphenix i with software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD. No remedy specified in recall notice.
Canon MedicalJan 31, 2022 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C,
Canon recalls TFP-800A flat panel detectors used with Alphenix systems due to risk of horizontal stripes causing catheter damage if images fail. Affected units have specific serial numbers.
Canon MedicalDec 20, 2021 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging
Canon recalls Vantage Titan 3T MRI systems with serial numbers starting with A5 or S7 for potential fire risk due to inadequate flame retardancy. Affected units may produce smoke or fire during use.
CanonMay 21, 2021 - Lower riskMedical device
Canon Medical System, USA, INC. recalls System INFX-8000C
Canon Medical recalls INFX-8000C X-ray systems with model CAS-880A/CAS-830B due to potential image shift at certain C-arm angles. Affected units may show inaccurate imaging.
Canon MedicalFeb 5, 2021 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE,
Canon recalls specific catheterization tables (INFX-8000F model) due to loose bolts that could cause table tilting. Affected units have unique serial numbers; contact Canon for remedy.
Canon MedicalDec 8, 2020 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical recalls PET-CT scanner model PCD-1000A due to software causing potential rescanning and contrast reinjection. Affected units have specific serial numbers.
Canon MedicalNov 11, 2020 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display
Canon recalls Aquilion Prime SP CT scanners with serial numbers listed for a software problem that may cause scans to fail, requiring rescanning and contrast reinjection.
CanonNov 9, 2020 - Use cautionMedical device
Canon Medical System, USA, INC. recalls CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers:
Canon Medical recalls CAS-930A Flat Panel Monitors used with Infinix-8000C/H systems due to potential cable breakage during procedures, risking patient vessel damage.
Canon MedicalOct 8, 2020 - Lower riskMedical device
Canon Medical System, USA, INC. recalls System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Canon Medical recalls Ultimax-i DREX-UI80 units with HDR-08A Imager Processor model where image counts differ from original during PACS transfer. Affected units have specific serial numbers listed in the recall notice.
Canon MedicalJul 8, 2020 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital
Canon recalls Infinix-8000F systems with CAT-850B or CAT-860B catheterization tables due to loose bolts causing table tilting. Affected units have specific serial numbers listed in the recall notice.
Canon MedicalMar 3, 2020 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Canon recalls certain Aquilion One CT scanners (TSX-305A/3 V8.3 with FIRST 2.1) due to scanning interruptions and potential data loss if the system fails to shut down properly.
CanonMar 25, 2019 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is
Canon Medical recalls Infinix DP-i (CAT-870B) catheterization tables that tilt unexpectedly when liquid spills into the tilt console, potentially causing patient falls. Affected models were sold from 2005-2008.
Canon MedicalFeb 8, 2019 - Lower riskMedical device
Canon Medical System, USA, INC. recalls Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is
Canon recalls Radrex-i X-Ray System software version v5.00ER005 due to image transmission failures during radiography. Affected units display error messages repeatedly when using wireless flat panel detectors.
Canon MedicalOct 16, 2018 - Use cautionMedical device
Canon Medical System, USA, INC. recalls Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces
Canon Medical recalls specific MRI systems (MEXL-1504 and MEXL-1510/MEXL-1520 models) where SAR values may be displayed lower than actual radiation levels during respiratory gating with Steady Mode ON in Spin Echo sequences.
Canon MedicalMay 30, 2018 - Lower riskMedical device
Canon Medical System, USA, INC. recalls DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Canon recalls DRAD-3000E (Radrex-i) wireless flat panel detectors that show image transmission errors during radiography. Affected units have specific serial numbers and were sold from 2001 to 2016. No remedy is provided in this recall.
CanonApr 18, 2018
Canon Medical System, USA, INC. recall questions
How many recalls has Canon Medical System, USA, INC. had?
51 recalls from Canon Medical System, USA, INC. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Canon Medical System, USA, INC. recall?
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5, dated Aug 26, 2026. Every Canon Medical System, USA, INC. recall is listed on this page, newest first.
What should I do if I have a recalled Canon Medical System, USA, INC. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Canon Medical System, USA, INC. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.