TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
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
- Why
- 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.
- Distributed
- 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.
- Company
- Cadwell Industries Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0141-2027 · retrieved 9 October 2026
Read the official notice