Monter: NeuroBlate System MRI Interaction Risk
Monteris Medical recalls NeuroBlate systems used in MRI-guided neurosurgery due to unanticipated interactions with 1.5 Tesla MRI machines. Affected units have all serial numbers.
Use caution until it’s fixed
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Contact the company
What happened, in plain English
Monteris Medical is recalling its NeuroBlate system for MRI-guided neurosurgery because it can interact unexpectedly with 1.5 Tesla MRI machines. This could create safety risks during procedures. Read more at govinfonow.com/recall/72901-monter-neuroblate-system-mri-interaction-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72901-monter-neuroblate-system-mri-interaction-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0194-2018
Cite this page
“Monter: NeuroBlate System MRI Interaction Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72901-monter-neuroblate-system-mri-interaction-risk. Based on FDA recall #Z-0194-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0194-2018%22&limit=1).
Why it’s dangerous
The NeuroBlate system can interact unexpectedly with 1.5 Tesla MRI machines, potentially causing safety issues during procedures. This interaction may lead to unintended effects on the medical device or patient.
Who’s affected
Healthcare professionals using the NeuroBlate system for MRI-guided neurosurgery are most at risk. Patients undergoing procedures with this system may also be affected.
How to tell if you have this one
The NeuroBlate system is used for MRI-guided neurosurgical ablation. All units have serial numbers, but the recall covers all models without specific distinctions.
- Brand
Monteris Medical- Category
Medical device
What to do — step by step
Check Your Serial Number
Look for the serial number on the NeuroBlate system to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0194-2018 (October 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0194-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.