# FDA recall Z-2338-2021

> **Hitachi Healthcare Americas Corporation** · Class II · device recall initiated 2021-07-29.

## Product

ECHELON Oval MRI System

## Reason for recall

There was no label on the pad packaging or notification in the user manual that  the table pads contained dry natural rubber which is required by the Code of  Federal Regulations section 21CFR801.437.

## Distribution

Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

## Key facts

- **Recall number:** Z-2338-2021
- **Recalling firm:** Hitachi Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-29
- **Report date:** 2021-09-01
- **Termination date:** 2023-09-08

- **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-2338-2021

## Citation

> AI Analytics. FDA recall Z-2338-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2338-2021. Source: US FDA. Licensed CC0.

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