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Terminated

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

FDA Recall Z-0194-2018 · Posted 2018-03-20

Recalling FirmMonteris Medical Corp
Recall StatusTerminated
Product CodeGEX
Date Initiated2017-10-05
Date Terminated2021-01-21
Product Quantity52 systems

Reason for Recall

The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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