Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

System INFX-8000F Recalled by Canon Medical System, USA, INC. Due to The x-ray irradiation field may shift with respect...

Date: February 5, 2021
Company: Canon Medical System, USA, INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.

Affected Products

System INFX-8000F

Quantity: 272 in total

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Canon Medical System, USA, INC.

Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report