FDA-Device2026-10-21Class IIPROCESSING DEFECT

Cadwell IOMAX Cortical Module recalled for defective circuit board causing unintended electrical stimulation

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

The IOMAX Cortical Module, a medical device used for electrical stimulation testing, contains a defective printed circuit board that may cause the device to deliver electrical stimulation to a patient unintentionally or allow unwanted electrical current to reach the patient. The issue affects 23 devices with specific serial numbers distributed in the US and internationally.

Check if your device serial number matches the affected list provided by Cadwell Industries.
Stop using the affected device immediately.
Contact Cadwell Industries for instructions on device replacement or repair.
Consult with your healthcare provider about alternative testing options during this time.

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The agency's original wording

Hazard

Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.

Affected count

Manufactured in

909 N Kellogg St, Kennewick, WA, United States

Products

Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2027

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