# FDA recall Z-0534-2021

> **Shimadzu Medical Systems** · Class II · device recall initiated 2020-11-09.

## Product

Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The 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.

## Reason for recall

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

## Distribution

US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.

## Key facts

- **Recall number:** Z-0534-2021
- **Recalling firm:** Shimadzu Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-09
- **Report date:** 2020-12-16

- **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-0534-2021

## Citation

> AI Analytics. FDA recall Z-0534-2021. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-0534-2021. Source: US FDA. Licensed CC0.

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