Canon Medical System recalls
16 official recalls and safety alerts involving Canon Medical System since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Canon Medical System or the relevant agency.
- 2026-10-14
USCanon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
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
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice →- 2026-09-02
- US
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 diagnostic and…
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.
FDA · DeviceCanon Medical System, USA, INC.U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and…Official notice → - 2026-02-04
- US
Canon Medical System, USA, INC. recalls 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,…
FDA · DeviceCanon Medical System, USA, INC.Worldwide distribution - US Nationwide and the country of Dominican Republic.Official notice → - 2026-01-21
- US
Canon Medical System, USA, INC. recalls 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…
FDA · DeviceCanon Medical System, USA, INC.U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD,…Official notice → - 2025-11-05
- US
Canon Medical System, USA, INC. recalls 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.
- 2025-10-15
- US
Canon Medical System, USA, INC. recalls This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The…
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…
- 2024-11-13
- US
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 Positron…
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…
FDA · DeviceCanon Medical System, USA, INC.US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VAOfficial notice → - 2024-06-19
- US
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), Vantage…
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…
FDA · DeviceCanon Medical System, USA, INC.US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ,…Official notice → - 2024-03-13
- US
Canon Medical System, USA, INC. recalls 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…
FDA · DeviceCanon Medical System, USA, INC.Worldwide - US Nationwide distribution including in the states of MD, IL, WV,…Official notice → - 2024-02-28
- US
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…
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…
- 2023-08-16
- US
Canon Medical System, USA, INC. recalls 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…
FDA · DeviceCanon Medical System, USA, INC.US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WAOfficial notice → - 2022-11-16
- US
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 CUS-AA550,…
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…
FDA · DeviceCanon Medical System, USA, INC.US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA,…Official notice → - 2022-09-07
- US
Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- 2022-07-06
- US
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, INFX-8000C/SW
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.
FDA · DeviceCanon Medical System, USA, INC.U.S.: CA, CO, FL, NY, and WY O.U.S.: NoneOfficial notice → - 2022-01-19
- US
Canon Medical System, USA, INC. recalls Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F,…
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…
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.Official notice → - 2021-10-27
- US
Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
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…
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of NV, AR MN.Official notice →