FDA recall Z-1216-2019

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-09-04

Report date

2019-05-15

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nazerat Illit, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2019