Device product
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Z-0194-2018
Product summary
- Event
- Event 78315
- Status
- Terminated
- Classification
- Class I
- Quantity
- 52 systems
- Official record key
device-enforcement:Z-0194-2018
Official wording
Reason: The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Code information: All serial numbers
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Unknown
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.