Class II

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

FUJIFILM Healthcare Americas Corporation · September 15, 2025

Reason for Recall

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.

Distribution

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

States Affected

AK, CA, FL, IL, MA, NH, OH, WI

Quantity Affected

16 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0044-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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