Cadwell Industries recalls specific Cascade IOMAX Cortical Module models due to potential incorrect installation of medical device insulators, which could cause unintended patient shock. Affected units have unique serial numbers listed in the recall notice.
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.
Cadwell Industries is recalling certain Cascade IOMAX Cortical Module medical devices because an insulator might be installed incorrectly, leading to possible patient shock. This recall affects specific models with unique serial numbers listed in the notice.
The device's insulator could be installed incorrectly, causing electrical arcing to patient connections. This arcing might result in unintended shocks to the patient during medical testing procedures.
Patients using this medical device for electroneurodiagnostic testing are most at risk. The recall applies to specific models sold with unique serial numbers listed in the notice.
Check the serial number on the device, which is listed in the recall notice (e.g., 19029603AA1223002, 19029603AA1223003, etc.). The product is a medical device used for electroneurodiagnostic testing.
Look for the serial number on the device, which should match one of the listed numbers in the recall notice.
Reach out to Cadwell Industries for guidance on whether the device needs repair or replacement.
The insulator may be installed incorrectly, causing electrical arcing to patient connections and potential unintended shocks during medical testing.
Check the serial number on the device against the list provided in the recall notice (e.g., 19029603AA1223002, 19029603AA1223003, etc.).
The recall does not require immediate stoppage; contact Cadwell Industries for specific guidance on whether the device needs repair or replacement.
We’ve drafted a message you can send Cadwell Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-1882-2024 — Cadwell Industries Cadwell Industries Hello, I own a Cadwell Industries that is covered by recall Z-1882-2024 from Cadwell Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
