FDA Device recall Z-1061-2015
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body
- FDA Device
- Class I
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class I recall of Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body by Alltech Medical Systems America, citing the MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1061-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-01-09 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alltech Medical Systems America |
| Distribution | MD |
Product
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Reason
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Identifiers
| code_info | Serial numbers: D-ESP-1001 and D-ESP-1003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1061-2015%22
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