Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1216-2019

September 04, 2018

Class I

Product summary

Firm
Alpha Omega Engineering
Event
Event 82540
Status
Terminated
Classification
Class I
Quantity
29
Official record key
device-enforcement:Z-1216-2019

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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