Tustin, CA, United States
Canon Medical System, USA, INC. recalls
28 recalls recorded since 2018, most recently on 26 August 2026. 22 are listed as ongoing. Status and classification are as published by the FDA.
Recalls28
Ongoing (FDA)22
Terminated or completed6
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 August 2026
- 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
- Distribution
- US Nationwide distribution in the state of ID.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0108-2027
Ongoing Class II Medical devices
- Recall started
- 4 August 2026
- 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.
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3014-2026
- 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 system is indicated for use in diagno
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- 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 vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1017-2026, Z-1018-2026
- VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- 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, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Distribution
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1177-2026, Z-1178-2026, Z-1179-2026, Z-1176-2026
- Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Alphenix INFX-8000H, interventional fluoroscopic x-ray system
- Alphenix INFX-8000V, interventional fluoroscopic x-ray system
- Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Ongoing Class II Medical devices
- Recall started
- 16 October 2025
- 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.
- Distribution
- US distribution to Ohio and Nevada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0327-2026
- VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Ongoing Class II Medical devices
- Recall started
- 2 September 2025
- 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 collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
- Distribution
- U.S.
- Initiated
- FDA Mandated
- Recall number
- Z-0037-2026
- 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 angiographic procedures for blood vessels in
Ongoing Class II Medical devices
- Recall started
- 17 September 2024
- 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 processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
- Distribution
- US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0284-2025
- 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 Tomography (CT) systems.
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- 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 cable, ignition, smoke, and fire.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2041-2024
- 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 MRT-3020 (MEXL-3020)
Ongoing Class II Medical devices
- Recall started
- 29 January 2024
- 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 manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- 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, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1249-2024, Z-1250-2024, Z-1248-2024
- MRI system: Vantage Elan, Model: MRT-2020
- Vantage Titan, Model: MRT-1504
- MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- 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 to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
- Distribution
- US: CA, LA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1155-2024, Z-1154-2024
- 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 computer enable the system to fully meet th
- 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 with an X-ray tube, beam limiter and X-ray
Ongoing Class II Medical devices
- Recall started
- 22 June 2023
- 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 using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
- Distribution
- US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2392-2023
- INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Ongoing Class II Medical devices
- Recall started
- 29 September 2022
- 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 this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0198-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 3 May 2022
- 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.
- Distribution
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1289-2022
- System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Ongoing Class II Medical devices
- Recall started
- 31 January 2022
- Reason
- The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-1666-2022
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Ongoing Class II Medical devices
- Recall started
- 20 December 2021
- 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 catheter from the patient's blood vessel and damage the blood vessel.
- Distribution
- US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0492-2022
- Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Ongoing Class II Medical devices
- Recall started
- 21 May 2021
- Reason
- The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- Distribution
- US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2046-2021, Z-2044-2021, Z-2045-2021, Z-2047-2021
- Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anato
- Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and obliq
- Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display an
- Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or
Ongoing Class II Medical devices
- Recall started
- 5 February 2021
- Reason
- The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
- Distribution
- Nationwide
- Initiated
- FDA Mandated
- Recall numbers
- Z-1175-2021, Z-1176-2021, Z-1174-2021
- System INFX-8000C
- System INFX-8000F
- System INFX-8000V
Ongoing Class II Medical devices
- Recall started
- 8 December 2020
- Reason
- System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1271-2021, Z-1270-2021, Z-1269-2021
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedu
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedu
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic proced
Terminated Class II Medical devices
- Recall started
- 11 November 2020
- Terminated
- 30 June 2023
- 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 diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
- Distribution
- US Nationwide distribution in the states of NV, AR MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0142-2022
- Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Terminated Class II Medical devices
- Recall started
- 9 November 2020
- Terminated
- 16 December 2022
- 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 resulting in rescanning and reinjection of contrast medium.
- Distribution
- US Nationwide distribution. OUS: Unknown
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0549-2021
- Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Terminated Class II Medical devices
- Recall started
- 8 October 2020
- Terminated
- 6 December 2022
- 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/or potential damage to the patients blood vessels due to removal without visibility.
- Distribution
- US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0532-2021
- CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy sys
Ongoing Class II Medical devices
- Recall started
- 8 July 2020
- 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.
- Distribution
- US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2885-2020
- System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Ongoing Class II Medical devices
- Recall started
- 3 March 2020
- Reason
- Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
- Distribution
- US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2327-2020, Z-2325-2020, Z-2326-2020
- Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indi
- Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indi
- Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indi
Ongoing Class II Medical devices
- Recall started
- 25 March 2019
- 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 acquired raw data would occur.
- Distribution
- Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1726-2020, Z-1724-2020, Z-1723-2020, Z-1719-2020, Z-1725-2020, Z-1722-2020, Z-1721-2020, Z-1720-2020
- Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
- Canon Aquilion Prime SP, Model TSX-303B
- Canon Aquilion Prime, Model TSX-303A
- Canon Aquilion Lightning, Model TSX-036A
- Canon Aquilion Precision, Model TSX-304A
- Canon Aquilion One Vision, Model TSX-301C
- Canon Aquilion Premium, Model TSX-301B
- Canon Aquilion One, Model TSX-301A
Terminated Class II Medical devices
- Recall started
- 8 February 2019
- Terminated
- 7 June 2022
- Reason
- Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0360-2020
- Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnosti
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 20 July 2020
- 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 image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
- Distribution
- US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1958-2019
- 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-ray system that employs Solid State Imager(s), SSXI, which converts x-rays
Ongoing Class II Medical devices
- Recall started
- 30 May 2018
- 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 may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY. International: Algeria, Australia, Bangladesh, Brazil, Canada, China, Colombia, Congo, Dominican Republic, Egypt, Guine
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0199-2019
- Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of t
Terminated Class II Medical devices
- Recall started
- 18 April 2018
- Terminated
- 13 May 2021
- Reason
- It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.
- Distribution
- Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2964-2018
- DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.