Cascade IOMAX Cortical Module, REF: 190296-200
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1882-2024