Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200

Recall date

May 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2349-2024

FDA classification

Class II

Brand / firm

Cadwell Industries Inc

Sold / distributed

US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom

Why it was recalled

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cascade IOMAX Cortical Module, REF: 190296-200