Class II — Potential Health Hazard

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

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: Recalled by Canon Medical System, USA, INC. Due to Bolts holding the longitudinal movement of catheterization tables...

Date: March 3, 2020
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

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 blood vessels in the heart, brain, abdomen and lower extremities.

Quantity: 24

Why Was This Recalled?

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

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