Recall Z-0194-2018 ยท GEX Powered Laser Surgical Instrument
Monteris Medical Corp
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
| Date | Mar 20, 2018 (initiated Oct 5, 2017) |
| Status | Terminated |
| Reason | The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. |
| Root cause | Device Design |
| Action | The firm issued advisory notice 10/05/2017. The notice discussed complaints received that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.5T) MRI systems. The notice provided added recommendations for all NeuroBlate users to mitigate the anomaly. |
| Quantity | 52 systems |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171255 | Monteris Medical NeuroBlate System Monteris Medical, Inc., Jul 25, 2017 |