FDAMay 17, 2024device
Cascade IOMAX Cortical Module, REF: 190296-200
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
cadwell
UPCs
00840067100653
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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