Class I — Monteris Medical Corp
| Recalling firm | Monteris Medical Corp |
|---|---|
| Registered facility | MONTERIS MEDICAL CORP (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. |
| Product | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. |
| Quantity | 52 systems |
| Distribution | Nationwide and Canada |
| Initiated | 2017-10-05 |
| Classified | 2018-03-20 |
| Terminated | 2021-01-21 |
| Recall number | Z-0194-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Monteris Medical Corp (Z-0194-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78315/
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