Hitachi Oasis MRI System — Class II medical device recall Z-1096-2017
Terminated recall by Hitachi Medical Systems America Inc, reported 2017-02-01, distributed nationwide. The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table
| Recall number | Z-1096-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2017-01-06 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 180 units |
Product
Hitachi Oasis MRI System - C-Spine Coil
Reason for recall
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
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-1096-2017. 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.