Drugs & medicalClass II

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…

Read the official notice →
Date
2025-10-15
Country
United States
Brand
Canon Medical System
Product
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is…
Classification
Class II
Units
U.S.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Canon Medical System recalls

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    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 →
  5. 2025-11-05
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    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.

    FDA · DeviceCanon Medical System, USA, INC.US distribution to Ohio and NevadaOfficial notice →
  7. 2024-11-13
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    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 →
  9. 2024-06-19
  10. US
    Drugs & medicalClass II

    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 →
  11. 2024-03-13
  12. US
    Drugs & medicalClass II

    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 →
All 16 Canon Medical System recalls →

Other drugs & medical recalls in the United States

  1. 2025-10-15
  2. US
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    Fresenius Medical Care Holdings, Inc. recalls Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX…

    To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the…

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    Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

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  7. US
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See all drugs & medical recalls →