# FDA recall Z-1039-2019

> **Shimadzu Medical Systems Usa Com** · Class II · device recall initiated 2019-01-14.

## Product

SHIMADZU MobileDaRt Evolution (MX8 Version), 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

In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle.  However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1039-2019
- **Recalling firm:** Shimadzu Medical Systems Usa Com
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-03-27
- **Termination date:** 2023-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2019

## Citation

> AI Analytics. FDA recall Z-1039-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1039-2019. Source: US FDA. Licensed CC0.

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