Device recall
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
- Recall number
- Z-0141-2027
- Event id
- 99774
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cadwell Industries Inc
- Report date
- Oct 21, 2026
- Posted
- Oct 9, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Oct 9, 2026
- Product code
- GWF
- Device type
- Stimulator, Electrical, Evoked Response
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 23
- Code info
- Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Lot Code: These devices are identified by the serial numbers listed below: 19029607AA0326007 19029607AA0226013 19029607AA0426028 19029607AA0226010 19029607AA0226007 19029607AA0326026 19029607AA0226015 19029607AA0326020 19029607AA0326018 19029607AA0326021 19029607AA0326022 19029607AA0226009 19029607AA0526022 19029607AA0326017 19029607AA0326027 19029607AA0326016 19029607AA0226016 19029607AA0326028 19029607AA0326024 19029607AA0326025 19029607AA0326023 19029607AA0326031 19029607AA0326006
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K162199
- Location
- Kennewick, WA, United States