# FDA recall Z-0044-2026

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2025-09-15.

## 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

- **Recall number:** Z-0044-2026
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-15
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0044-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0044-2026. Source: US FDA. Licensed CC0.

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