Every recall we track for Canon Medical System, USA, INC. — 50 in all — plus the complaints and injury reports the public filed about them.
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 Medical recalls Alphenix INFX-8000C interventional fluoroscopy systems with loose ceiling screws that could cause movement issues or sensor errors. Affected units have specific serial numbers.
Canon recalls Alphenix INFX-8000V interventional fluoroscopic x-ray systems with possible loose ceiling movement gear screws causing loss of lateral movement, noise, and sensor errors.
Canon Medical recalls Alphenix INFX-8000H interventional fluoroscopy systems due to potential ceiling movement issues from loose screws. Affected units have specific serial numbers.
Canon Medical recalls Vantage Titan 3T MRI systems with potential ice formation in venting that could cause helium vessel rupture if a quench occurs. Affected models include MRT-3010/MEXL-3010 with specific serial numbers.
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.
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 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 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 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 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 Medical recalls Vantage Orian and Vantage Fortian MRI systems (MRT-1550) due to incorrect spatial field gradient values potentially causing patient discomfort during scans. Affected units have specific serial numbers and UDI-DI codes.
Canon Medical recalls Vantage Titan MRI systems with model MRT-1504 due to incorrect Spatial Field Gradient values potentially causing patient discomfort during scans. Affected units have specific serial numbers.
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 Medical recalls X-ray systems that may display horizontal stripes, causing exams to stop or requiring alternative imaging. Affected units have specific UDI-DI and serial numbers.
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 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 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.
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 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 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 recalls Vantage Galan 3T MRI systems (MRT-3020) due to potential fire risk from inadequate flame retardancy. Affected units include specific serial numbers listed in the recall notice.
Canon Medical recalls 1.5T MRI systems with potential fire risk due to inadequate flame retardancy. Affected units may produce smoke or fire during use. Consumers should contact Canon for details.
Canon Medical recalls Toshiba Vantage Tiitan 1.5T MRI systems with specific serial numbers for potential fire risk from inadequate flame retardancy. Affected units may produce smoke or fire during operation.
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.
Canon Medical recalls INFX-8000V X-ray systems with model CAS-880A/CAS-830B due to potential image shift at certain C-arm angles. Affected units may require correction to prevent imaging errors.
Canon Medical recalls INFX-8000F X-ray systems with CAS-880A/CAS-830B models due to potential image shift at certain C-arm angles. Affected units may require correction to prevent imaging errors.
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 recalls specific catheterization tables (INFX-8000V models) due to potential loose bolts causing table tilt. Affected units may require inspection or repair.
Canon recalls specific catheterization tables (INFX-8000C models) due to loose bolts that may cause the table to tilt. Affected units include certain serial numbers and model combinations.
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 Medical recalls PET-CT scanner model PCD-1000A due to software causing potential rescanning and contrast reinjection. Affected units have specific serial numbers.
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.
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 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 recalls Infinix-8000C catheterization tables with CAT-850B or CAT-860B models due to loose bolts causing table tilting. Affected units have specific serial numbers listed in the recall notice.
Canon recalls Infinix-8000V systems with CAT-850B or CAT-860B tables due to loose bolts causing table tilting. Affected units have specific serial numbers listed in the recall notice.
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 recalls Aquilion One TSX-301A CT scanners due to scanning interruptions causing data loss. Affected units have specific serial numbers.
Canon recalls its Aquilion Premium TSX-301B CT scanners due to scanning interruptions and potential data loss if the system cannot shut down normally. Affected units have specific serial numbers.
Canon recalls its Aquilion One Vision TSX-301C CT scanner due to scanning interruptions and potential data loss if the system cannot shut down normally. Affected units have specific serial numbers.
Canon recalls its Aquilion Precision TSX-304A CT scanners due to scanning interruptions that can cause data loss. Affected units may require forced shutdowns and reboots.
Canon recalls specific Aquilion Lightning models (TSX-036A) due to scanning interruptions causing data loss. Affected units have unique serial numbers listed in the recall notice.
Canon recalls Aquilion Prime TSX-303A MRI systems where scanning errors may cause data loss. Affected units have specific serial numbers listed in the recall notice.
Canon recalls specific model CT scanners due to scanning errors causing data loss. Affected units may require forced shutdowns. Contact Canon for details.
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.
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 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 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 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.
