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Terminated

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

FDA Recall Z-1216-2019 · Posted 2019-05-06

Recalling FirmAlpha Omega Engineering
Recall StatusTerminated
Product CodeGZL
Date Initiated2018-09-04
Date Terminated2020-11-03
Product Quantity29

Reason for Recall

If cables are improperly connected, current may reach high charge density, causing tissue harm.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171581Neuro Omega SystemAlpha Omega Engineering , Ltd. · 2017-12-22K123796NEURO OMEGA SYSTEMAlpha Omega Engineering , Ltd. · 2013-04-05

Official Source

View FDA Recall →

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

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