Echostar Spica 1 — Class I medical device recall Z-1061-2015
Terminated recall by Alltech Medical Systems America Inc, reported 2015-02-25, distributed in MD. The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly
| Recall number | Z-1061-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alltech Medical Systems America Inc, Solon, OH, United States |
| Recall initiated | 2015-01-09 |
| Classified | 2015-02-18 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-09-15 |
| Distributed | MD |
| Quantity | 2 units |
| Serial numbers | D-ESP-1001, D-ESP-1003 |
Product
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Reason for recall
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
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-1061-2015. 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.