Class II — Potential Health Hazard

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

Fujifilm FDR Go PLUS Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became...

Date: January 15, 2019
Company: Fujifilm Medical Systems U.S.A., 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 Fujifilm Medical Systems U.S.A., Inc. directly.

Affected Products

Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

Quantity: 56 units

Why Was This Recalled?

FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

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