Canon Medical System Usa recalls
Canon Medical System Usa appears in 51 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 51 |
|---|---|
| Published | 2018-09-12 to 2026-10-14 |
| By agency | FDA Device (51) |
| By classification | Class II (51) |
| By status | ongoing (45), terminated (6) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Alphenix INFX-8000C/B5
FDA Device · Class II · 2026-10-14 · Canon Medical System Usa
Reason: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error - Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent…
FDA Device · Class II · 2026-09-02 · Canon Medical System Usa
Reason: 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. - Alphenix INFX-8000V, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
Reason: 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, ceilin… - Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
Reason: 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, ceilin… - Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
Reason: 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, ceilin… - Alphenix INFX-8000C, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
Reason: 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, ceilin… - VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
FDA Device · Class II · 2026-01-21 · Canon Medical System Usa
Reason: 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 ven… - VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
FDA Device · Class II · 2026-01-21 · Canon Medical System Usa
Reason: 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 ven… - VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7
FDA Device · Class II · 2025-11-05 · Canon Medical System Usa
Reason: 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. - This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration
FDA Device · Class II · 2025-10-15 · Canon Medical System Usa
Reason: 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 collimate… - Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomo…
FDA Device · Class II · 2024-11-13 · Canon Medical System Usa
Reason: 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 processin… - MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MR…
FDA Device · Class II · 2024-06-19 · Canon Medical System Usa
Reason: 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… - Vantage Titan, Model: MRT-1504
FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
Reason: 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 m… - MRI system: Vantage Elan, Model: MRT-2020
FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
Reason: 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 m… - MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
Reason: 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 m… - The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time
FDA Device · Class II · 2024-02-28 · Canon Medical System Usa
Reason: 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… - The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting
FDA Device · Class II · 2024-02-28 · Canon Medical System Usa
Reason: 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… - INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
FDA Device · Class II · 2023-08-16 · Canon Medical System Usa
Reason: 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 u… - Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CU…
FDA Device · Class II · 2022-11-16 · Canon Medical System Usa
Reason: 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… - INFX-8000V. For radiographic and fluoroscopic studies and intervention
FDA Device · Class II · 2022-09-07 · Canon Medical System Usa
Reason: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. - System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
FDA Device · Class II · 2022-07-06 · Canon Medical System Usa
Reason: 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. - Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-800…
FDA Device · Class II · 2022-01-19 · Canon Medical System Usa
Reason: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a cath… - Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
FDA Device · Class II · 2021-10-27 · Canon Medical System Usa
Reason: A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagn… - Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imagin…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa
Reason: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. - Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cro…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa
Reason: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. - Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coron…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa
Reason: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. - Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa
Reason: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. - Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 2…
FDA Device · Class II · 2021-03-24 · Canon Medical System Usa
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. - System INFX-8000V
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa
Reason: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. - System INFX-8000C
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa
Reason: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. - System INFX-8000F
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa
Reason: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. - Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volume…
FDA Device · Class II · 2020-12-16 · Canon Medical System Usa
Reason: A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resu… - CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and In…
FDA Device · Class II · 2020-12-09 · Canon Medical System Usa
Reason: There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/o… - System Model: Ultimax-i, DREX-UI80 (DREX-UI80)
FDA Device · Class II · 2020-09-02 · Canon Medical System Usa
Reason: During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired. - Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. - Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. - Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa
Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. - Canon Aquilion Prime, Model TSX-303A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion Premium, Model TSX-301B
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion Lightning, Model TSX-036A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion One Vision, Model TSX-301C
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion One, Model TSX-301A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion Precision, Model TSX-304A
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Canon Aquilion Prime SP, Model TSX-303B
FDA Device · Class II · 2020-04-22 · Canon Medical System Usa
Reason: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquir… - Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F…
FDA Device · Class II · 2019-11-20 · Canon Medical System Usa
Reason: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. - 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…
FDA Device · Class II · 2019-07-17 · Canon Medical System Usa
Reason: software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no im… - Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transa…
FDA Device · Class II · 2018-10-31 · Canon Medical System Usa
Reason: When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values m…