# FDA recall Z-0271-2020

> **Hitachi Medical Systems America Inc** · Class II · device recall initiated 2019-10-16.

## Product

Hitachi Scenaria Whole-body X-ray CT System

## Reason for recall

There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

## Distribution

The devices were distributed to the following US states:  CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR.    The products were distributed to the following foreign countries:  Brazil and Mexico.

## Key facts

- **Recall number:** Z-0271-2020
- **Recalling firm:** Hitachi Medical Systems America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-16
- **Report date:** 2019-11-13
- **Termination date:** 2020-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Twinsburg, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2020

## Citation

> AI Analytics. FDA recall Z-0271-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0271-2020. Source: US FDA. Licensed CC0.

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