# FDA recall Z-1898-2024

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2024-04-11.

## Product

FDR Visionary Suite - 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.    Model/Catalog Number:  566-16130-23  566-16130-33

## Reason for recall

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

## Distribution

US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

## Key facts

- **Recall number:** Z-1898-2024
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-11
- **Report date:** 2024-06-05

- **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-1898-2024

## Citation

> AI Analytics. FDA recall Z-1898-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1898-2024. Source: US FDA. Licensed CC0.

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