FDA recall Z-0044-2026

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-09-15
Report date: 2025-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2026