Z-1061-2015 Class I Terminated
FDA device recall Z-1061-2015 was initiated by Alltech Medical Systems America Inc on January 9, 2015 and is designated Class I. Reason for recall: The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly. The recall status is terminated (terminated September 15, 2015). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2015
- Initiation Date
- January 9, 2015
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
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.
Distribution Pattern
US Distribution in the state of Maryland.
Code Information
Serial numbers: D-ESP-1001 and D-ESP-1003