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Canon Medical System, USA, INC.

Canon Medical System, USA, INC. Recalls

All product recalls associated with Canon Medical System, USA, INC..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–26 of 26 recalls

Canon Medical System, USA, INC.: System INFX-8000V

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Moderate

FDAFeb 5, 2021Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V ...

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Moderate

FDADec 8, 2020Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Mode...

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.

Moderate

Page 2 of 2Next

FDA

Jul 8, 2020

CA, CT, ID +7 more

• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Infinix-8000V with Catheterization Table CAT-850B or CAT-...

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Moderate

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Infinix-8000C with Catheterization Table CAT-850B or CAT-...

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Moderate

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Infinix-8000F with Catheterization Table CAT-850B or CAT-...

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Moderate

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.