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 AQRO (Model DR-XD1000)- A digital mobile X-ray system Recalled by FUJIFILM Healthcare Americas Corporation Due to Arm which holds the tube head in place...

Date: February 27, 2023
Company: FUJIFILM Healthcare Americas Corporation
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 FUJIFILM Healthcare Americas Corporation directly.

Affected Products

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams

Quantity: 77 units

Why Was This Recalled?

Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About FUJIFILM Healthcare Americas Corporation

FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

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