Device product
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Z-1061-2015
Product summary
- Event
- Event 70238
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1061-2015
Official wording
Reason: The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Code information: Serial numbers: D-ESP-1001 and D-ESP-1003
Distribution pattern: US Distribution in the state of Maryland.
Derived failure modes
-
Unknown
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.