FDA Device recall Z-2337-2021
ECHELON MRI System
- FDA Device
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of ECHELON MRI System by Hitachi Healthcare Americas, citing 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 se….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2337-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-29 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hitachi Healthcare Americas |
| Distribution | US |
Product
ECHELON MRI System
Reason
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.
Identifiers
| code_info | V001-V070, V952 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2337-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.