Recall Z-2688-2016 ยท MOS Coil, Magnetic Resonance, Specialty
Invivo Corporation
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
| Date | May 6, 2016 |
| Status | Terminated |
| Reason | A diode was inadvertently not assembled into the system, which may result in coil overheating |
| Root cause | Under Investigation by firm |
| Quantity | 3 |
| Distribution | WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 Sentinelle Medical, Inc., Apr 22, 2010 |