| Class 1 Device Recall Neuro Omega | |
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 | K123796 K171581 |
Product Classification |
Electrode, depth - Product Code GZL
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GZL 510(K)s with Product Code = GZL
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