Cadwell Industries Inc is recalling 54 units of the Cascade IOMAX Cortical Module, a medical device used during neurodiagnostic procedures. An internal insulator component may have been installed incorrectly, which can cause electrical arcing to patient connections. This defect can lead to an unintended electrical shock to the patient during medical monitoring. Consumers should contact the manufacturer immediately for guidance on checking and servicing their devices.
The incorrectly installed insulator allows electricity to jump or 'arc' to the patient connections instead of being contained. This poses a direct risk of delivering an unintended electrical shock to a patient undergoing a procedure.
Manufacturer initiated recall and inspection
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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