medical Class I Updated 2019-05-15

Alpha Omega Engineering recalls Neuro Omega System, incorporating HaGuide software. For n

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

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