The Recall Desk

Manufacturer

Canon Medical System, USA, INC.

50 recalls in our database name Canon Medical System, USA, INC. as the manufacturing or recalling firm.

What the numbers show

Total
50
Critical
0
Severe
2
Most recent
2026-09-02

Of the 50 recalls from Canon Medical System, USA, INC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 50

  • HighFDA (Devices)·Z-3014-2026·2026-09-02

    Canon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws

    Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.

    Product
    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 diagnostic and angiographic procedures for blood vessels in the he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2026·2026-02-04

    Q.namix R fluoroscopy systems recalled over unflipped and mismatched images

    Siemens is recalling 41 units of the LUMINOS Q.namix R fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.

    Product
    Alphenix INFX-8000V, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1177-2026·2026-02-04

    Alphenix INFX-8000F systems recalled over ceiling suspension screws that loosen

    Canon Medical Systems is recalling 98 units of the Alphenix INFX-8000F because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.

    Product
    Alphenix INFX-8000F, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2026·2026-02-04

    Alphenix INFX-8000H systems recalled over ceiling suspension screws that loosen

    Canon Medical Systems is recalling 3 units of the Alphenix INFX-8000H because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.

    Product
    Alphenix INFX-8000H, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1176-2026·2026-02-04

    Alphenix INFX-8000C systems recalled over ceiling suspension screws that loosen

    Canon Medical Systems is recalling 172 units of the Alphenix INFX-8000C because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.

    Product
    Alphenix INFX-8000C, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2026·2026-01-21

    MRI systems recalled over ice that may block magnet venting

    Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.

    Product
    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1017-2026·2026-01-21

    Allura Xper FD20 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.

    Product
    VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2026·2025-11-05

    MRI systems recalled over electrode spacing below the required safety standard

    Canon Medical Systems is recalling two Vantage Galan 3T MRI systems because components do not meet the required distance between electrodes for IEC 60601-1 compliance.

    Product
    VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0037-2026·2025-10-15

    Angiography systems recalled over collimator returning to default region of interest

    Canon Medical Systems is recalling eight radiography/fluoroscopy systems because changing the acquisition program returns the collimator to a default ROI, leaving the X-ray area partially covered by a static image.

    Product
    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 the heart, brain, abdomen and lower extremities.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0284-2025·2024-11-13

    Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction

    27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.

    Product
    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.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2041-2024·2024-06-19

    MRI Systems Power Cable Terminal Block Fire Hazard Recall

    Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.

    Product
    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)
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-1250-2024·2024-03-13

    MRI System Spatial Field Gradient Values Incorrectly Displayed and Documented

    Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.

    Product
    Vantage Titan, Model: MRT-1504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2024·2024-03-13

    MRI System Displays Incorrect Field Gradient Safety Values

    Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.

    Product
    MRI system: Vantage Elan, Model: MRT-2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2024·2024-02-28

    X-Ray C-Arm System Internal Board Defect Causes Abnormal Images

    Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.

    Product
    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 receptor, X-ray controller, computers with system and proce
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1155-2024·2024-02-28

    X-ray fluoroscopy system may display abnormal images due to detector board defect

    Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.

    Product
    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 the requirement for optimum image quality, safety, ease of use
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2392-2023·2023-08-16

    Canon Medical INFX-8000C Tableside Console PWB Requires Replacement

    Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.

    Product
    INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2023·2022-11-16

    Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images

    Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.

    Product
    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
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1666-2022·2022-09-07

    Radiographic imaging system may exceed radiation dose limits in biplane mode

    Canon Medical's Alphenix i imaging systems may deliver radiation dose rates exceeding acceptable limits during biplane fluoroscopic procedures. Sixteen systems nationwide with software versions 8.0, 9.0, or 9.2 and TFP 1200C detector are affected.

    Product
    INFX-8000V. For radiographic and fluoroscopic studies and intervention.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2022·2022-07-06

    Alphenix 4D CT system may stop operating due to system error

    The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.

    Product
    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0492-2022·2022-01-19

    Flat Panel Detector May Display Abnormal Images During Surgical Procedures

    Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.

    Product
    Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2022·2021-10-27

    Canon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures

    Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.

    Product
    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2021·2021-07-21

    Toshiba Vantage MRI System Recalled for Flame Retardancy Defect

    Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were distributed nationwide.

    Product
    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 oblique images that display anatomic structures of the head or bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2021·2021-07-21

    Canon MRI System Recalled for Flame-Retardancy Component Defect

    Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.

    Product
    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 anatomic structures of the head or body. Additionally, this syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2021·2021-07-21

    Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure

    Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.

    Product
    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 anatomic structures of the head or body. Additionally, this sy
    Category
    Medical Device
    Distribution
    Distributed nationwide