MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
FDA device recall Z-0194-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- Monteris Medical Corp
- Reason for recall
- The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 52 systems
- Distribution
- Nationwide and Canada
- Date initiated
- 2017-10-05
- Date posted
- 2018-03-20
- Date terminated
- 2021-01-21
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Monteris Medical NeuroBlate System (K171255) | Monteris Medical, Inc. | 2017-07-25 |