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Alpha Omega Engineering recalls Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record an
Recalled May 15, 2019 · FDA recall Z-1216-2019 · Alpha Omega Engineering
Hazard
If cables are improperly connected, current may reach high charge density, causing tissue harm. · FDA Class I
Units
29
Sold at
US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
Description
If cables are improperly connected, current may reach high charge density, causing tissue harm.
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.
Manufacturer(s)
Alpha Omega Engineering
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →