FDAApril 23, 2024device
Cascade IOMAX Cortical Module, REF: 190296-200
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
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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