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U.S. Department of Health and Human Services

Class 1 Device Recall MONTERIS MEDICAL NEUROBLATE SYSTEM

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  Class 1 Device Recall MONTERIS MEDICAL NEUROBLATE SYSTEM see related information
Date Initiated by Firm October 05, 2017
Date Posted March 20, 2018
Recall Status1 Terminated 3 on January 21, 2021
Recall Number Z-0194-2018
Recall Event ID 78315
510(K)Number K171255  
Product Classification Powered laser surgical instrument - Product Code GEX
Product MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Monteris Medical Corp
14755 27th Ave N Ste C
Plymouth MN 55447-4866
Manufacturer Reason
for Recall		 The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = Monteris Medical, Inc.
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