Z-0194-2018Class I

MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation

Name: Z-0194-2018 MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation
Creator: Monteris Medical Corp
Published: 2017-10-05
License: https://open.fda.gov/license/

Monteris Medical Corp / initiated 2017-10-05 / Terminated / root cause: design

FDA source

Monteris Medical Corp began a recall of MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation on 2017-10-05. FDA classified it as Class I and gives the reason as "The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0194-2018
Classification: Class I
Status: Terminated
Initiated: 2017-10-05
Posted: 2018-03-20
Terminated: 2021-01-21
Recalling firm: Monteris Medical Corp
Product: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 52 systems
Distribution: Nationwide and Canada
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0194-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20

Product code GEX

K171255Class IIMonteris Medical NeuroBlate SystemMonteris Medical, Inc. / cleared 2017-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)