# FDA recall Z-1470-2023

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2023-02-27.

## Product

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams

## Reason for recall

Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1470-2023
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-27
- **Report date:** 2023-05-03

- **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-1470-2023

## Citation

> AI Analytics. FDA recall Z-1470-2023. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1470-2023. Source: US FDA. Licensed CC0.

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