Z-1216-2019Class I

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor...

Name: Z-1216-2019 Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor...
Creator: Alpha Omega Engineering
Published: 2018-09-04
License: https://open.fda.gov/license/

Alpha Omega Engineering Ltd. / initiated 2018-09-04 / Terminated / root cause: design

FDA source

Alpha Omega Engineering began a recall of Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate... on 2018-09-04. FDA classified it as Class I and gives the reason as "If cables are improperly connected, current may reach high charge density, causing tissue harm". 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-1216-2019
Classification: Class I
Status: Terminated
Initiated: 2018-09-04
Posted: 2019-05-06
Terminated: 2020-11-03
Recalling firm: Alpha Omega Engineering Ltd.
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.
Product code: GZL Electrode, Depth
Reason for recall: If cables are improperly connected, current may reach high charge density, causing tissue harm.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2019	Class I	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06

Product code GZL

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)