FDA-Device2024-05-29Class II
Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries Inc
Hazard
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.
Sold states
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.
Affected count
54 units
Manufactured in
909 N Kellogg St, Kennewick, WA, United States
Products
Cascade IOMAX Cortical Module, REF: 190296-200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1882-2024Don't want to check this manually?
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