Alpha Omega Engineering recalls Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and disp…

Recall date

September 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1216-2019

FDA classification

Class I

Brand / firm

Alpha Omega Engineering

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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