Medical Device Recall: Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries Inc · April 23, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
54 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1882-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.