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.

26–50 of 50

  • HighFDA (Devices)·Z-2047-2021·2021-07-21

    Canon Vantage Galan 3T MRI System Recalled for Fire Risk

    Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.

    Product
    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 body. Additionally, this system is capable of non-contrast e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2021·2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because table fastening bolts may loosen, causing the table to tilt.

    Product
    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 procedures for blood vessels in the heart, brain, abdomen, and low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2021·2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 interventional angiography systems because the table may tilt if fastening bolts become loose.

    Product
    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 procedures for blood vessels in the heart, brain, abdomen, and lowe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2021·2021-03-24

    Canon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because loose bolts may cause the table to tilt.

    Product
    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 procedures for blood vessels in the heart, brain, abdomen, and lowe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2021·2021-03-17

    Canon Medical System INFX-8000C C-Arm Recall for X-Ray Field Shift

    Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.

    Product
    System INFX-8000C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2021·2020-12-16

    Canon CT Scanner Recall for Software Issue Causing Scan Failures

    Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2021·2020-12-09

    Canon Flat Panel Monitor Recall Due to Cable Breakage Risk

    Canon Medical System is recalling 14 CAS-930A Flat Panel Monitors because the cable may break during procedures, potentially causing delays or vessel damage.

    Product
    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 system used in a diagnostic and interventional angiography conf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2885-2020·2020-09-02

    Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors

    Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.

    Product
    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2326-2020·2020-06-17

    Canon Medical System Recalls 24 Infinix-8000C Digital Radiography Systems

    Canon Medical System is recalling 24 Infinix-8000C digital radiography systems because loose bolts may cause the catheterization table to tilt.

    Product
    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 indicated for use in diagnostic and angiographic procedures for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2020·2020-06-17

    Canon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts

    Canon Medical System is recalling 15 Infinix-8000F digital radiography systems because loose bolts may cause the catheterization table to tilt.

    Product
    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 indicated for use in diagnostic and angiographic procedures for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2020·2020-06-17

    Canon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts

    Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.

    Product
    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 indicated for use in diagnostic and angiographic procedures for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1726-2020·2020-04-22

    Canon Aquilion One CT Scanner Recall for System Interruption

    Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.

    Product
    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1724-2020·2020-04-22

    Canon Aquilion Prime SP CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling 10 Aquilion Prime SP CT scanners because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Prime SP, Model TSX-303B
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1723-2020·2020-04-22

    Canon Aquilion Prime CT Scanner Recalled for System Shutdown Errors

    Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.

    Product
    Canon Aquilion Prime, Model TSX-303A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1722-2020·2020-04-22

    Canon Aquilion One Vision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion One Vision, Model TSX-301C
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1721-2020·2020-04-22

    Canon Aquilion Premium CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling two Aquilion Premium CT scanners because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion Premium, Model TSX-301B
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1720-2020·2020-04-22

    Canon Aquilion One CT Scanner Recalled for Scanning Interruption Errors

    Canon Medical System is recalling two Aquilion One CT scanners because scanning errors may interrupt exams and force system reboots, resulting in the loss of acquired raw data.

    Product
    Canon Aquilion One, Model TSX-301A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1719-2020·2020-04-22

    Canon Aquilion Lightning CT Scanner Recalled for System Shutdown Errors

    Canon Medical System is recalling six Aquilion Lightning CT scanners because a software error can interrupt scanning and prevent normal shutdown, causing loss of raw data.

    Product
    Canon Aquilion Lightning, Model TSX-036A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1725-2020·2020-04-22

    Canon Aquilion Precision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Precision, Model TSX-304A
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-0360-2020·2019-11-20

    Canon Medical Recalls Infinix DP-i Catheterization Tables Due to Unintended Tilting

    Canon Medical System, USA, INC. is recalling nine Infinix DP-i catheterization tables because liquid spills can trigger a short circuit, causing the table to tilt without operator control.

    Product
    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 diagnostic and interventional x-ray angiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2019·2019-07-17

    Canon Radrex-i X-Ray System Software Malfunction Recall

    Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

    Product
    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 directly into electrical signals which can, after appropriat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2019·2018-10-31

    Canon MRI Systems Recall Due to SAR Display Error

    Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.

    Product
    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 the head or body.
    Category
    Medical Device
    Distribution
    41 states