Recall Z-1061-2015 ยท LNH System, Nuclear Magnetic Resonance Imaging
Alltech Medical Systems America Inc
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
| Date | Feb 18, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2 units |
| Distribution | US Distribution in the state of Maryland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113511 | ECHOSTAR SPICA 1.5T MR SYSTEM Alltech Medical Systems America, Inc., May 2, 2012 |