Home / Recalls / Alpha Omega Engineering / Z-1216-2019

Z-1216-2019 Class I Terminated

Recalled by Alpha Omega Engineering — Nazerat Illit, N/A

Recall Details

Product Type: Devices
Report Date: May 15, 2019
Initiation Date: September 4, 2018
Termination Date: November 3, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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.