Recall Z-1046-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355
| Date | Mar 25, 2008 (initiated Dec 1, 2007) |
| Status | Terminated |
| Reason | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Root cause | Device Design |
| Action | The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies. |
| Quantity | 1 unit |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971684 | MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) Siemens Medical Solutions USA, Inc., Aug 5, 1997 |