# FDA recall Z-1040-2019

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2019-01-15.

## Product

Fujifilm FDR Go PLUS,  Mobile X-Ray System    Product Usage:  This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

## Reason for recall

FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1040-2019
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-03-27
- **Termination date:** 2020-10-08

- **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-1040-2019

## Citation

> AI Analytics. FDA recall Z-1040-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1040-2019. Source: US FDA. Licensed CC0.

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