# FDA recall Z-3158-2024

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2023-11-23.

## Product

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

## Reason for recall

When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

## Distribution

US Nationwide and Worldwide

## Key facts

- **Recall number:** Z-3158-2024
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-23
- **Report date:** 2024-10-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3158-2024

## Citation

> AI Analytics. FDA recall Z-3158-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-3158-2024. Source: US FDA. Licensed CC0.

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