# FDA recall Z-0232-2018

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2017-06-15.

## Product

FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name)    The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.

## Reason for recall

A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube  mounting flange.

## Distribution

US Distribution.

## Key facts

- **Recall number:** Z-0232-2018
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2017-12-20
- **Termination date:** 2018-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stamford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2018

## Citation

> AI Analytics. FDA recall Z-0232-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0232-2018. Source: US FDA. Licensed CC0.

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