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Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200
Recalled May 29, 2024 · FDA recall Z-1882-2024 · Cadwell Industries
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. · FDA Class II
Units
54 units
Sold at
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.
Description
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.
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Manufacturer(s)
Cadwell Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →