FDA Device recall Z-0194-2018
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation
- FDA Device
- Class I
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class I recall of MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation by Monteris Medical, citing the firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0194-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-10-05 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Monteris Medical |
| Distribution | US |
Product
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Reason
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0194-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.