Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
This recall has been terminated (originally issued February 18, 2015).
- Recall Initiated
- January 9, 2015
- Posted
- February 18, 2015
- Terminated
- September 15, 2015
- Recall Number
- Z-1061-2015
- Quantity
- 2 units
- Firm Location
- Solon, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Distribution
US Distribution in the state of Maryland.
Lot / Code Info
Serial numbers: D-ESP-1001 and D-ESP-1003
Root Cause
Process control
Action Taken
Altech Medical Systems America Inc., notified customers on January 9, 2015, of the problem via telephone. Customers were instructed to immediately cease using the product until the correction can be made. A follow-up letter was sent through the mail, which stated that a service engineer would make a site visit to ramp down the magnet until the issue can be corrected. Customers were asked to complete the attached Acknowledgement and Receipt Form and fax it to (440) 424-2255. For questions contact AMSA at 1-855-200-2672.