Class II — Potential Health Hazard

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

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) Recalled by Canon Medical System, USA, INC. Due to It was found when an operator performs a...

Date: April 18, 2018
Company: Canon Medical System, USA, INC.
Status: Terminated
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

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Quantity: 43

Why Was This Recalled?

It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.

Where Was This Sold?

This product was distributed to 17 states: AR, FL, GA, IL, LA, MI, NJ, NY, NC, OH, PA, TN, TX, UT, VT, WV, WI

Affected (17 states)Not affected

About Canon Medical System, USA, INC.

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

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