FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Recall date

September 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0044-2026

FDA classification

Class II

Brand / firm

FUJIFILM Healthcare Americas Corporation

Sold / distributed

Domestic: AK, CA, FL, IL, MA, NH, OH, WI.

Why it was recalled

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33