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U.S. Department of Health and Human Services

Class 1 Device Recall Neuro Omega

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  Class 1 Device Recall Neuro Omega see related information
Date Initiated by Firm September 04, 2018
Date Posted May 06, 2019
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-1216-2019
Recall Event ID 82540
510(K)Number K171581  K123796  
Product Classification Electrode, depth - Product Code GZL
Product Neuro Omega System, incorporating HaGuide software.
For neurological and neurosurgical use.
To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Code Information Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189. 
Recalling Firm/
Manufacturer		 Alpha Omega Engineering
PO Box 810, Haavoda Street
Nazerat Illit Israel
Manufacturer Reason
for Recall		 If cables are improperly connected, current may reach high charge density, causing tissue harm.
FDA Determined
Cause 2		 Device Design
Action The firm originally notified customers of the issue via email on September 4, 2018. Also, another updated notification Urgent Field Safety Notice, Neuro Omega system, DATE March 4, 2019, Field Advisory Note [FAN] Attention: Details on affected devices: Neuro Omega system with: Catalogue number: (Neuro Omega) NOM-000000-00 + (Drive) 750-000020-00 + (EMG) 750-000010-00 + (EEG) 750-000010-12 Software version number: Any, clarifying that the issue only occurred in a triple-fault condition.
Quantity in Commerce 29
Distribution US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
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 = GZL and Original Applicant = Alpha Omega Engineering Ltd,
510(K)s with Product Code = GZL and Original Applicant = ALPHA OMEGA ENGINEERING LTD.
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