ECHELON MRI System — Class II medical device recall Z-2337-2021
Terminated recall by Hitachi Healthcare Americas Corporation, reported 2021-09-01, distributed nationwide. There was no label on the pad packaging or notification in the user manual that the table pads contained dry n
| Recall number | Z-2337-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Healthcare Americas Corporation, Twinsburg, OH, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2021-08-24 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, MX |
| Reason classes | labeling |
Product
ECHELON 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2337-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.