FDA-Device2024-07-24Class II
Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries Inc
Hazard
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Sold states
US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
Affected count
26 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-2349-2024Don't want to check this manually?
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