Alpha Omega Engineering: Medical Device Recall in 2019 - (Recall #: Z-1216-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: September 4, 2018

Date Posted: May 15, 2019

Recall Number: Z-1216-2019

Event ID: 82540

Reason for Recall:

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

Status: Terminated

Product Quantity: 29

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated