Recall Z-0141-2027
- Recall number
- Z-0141-2027
- Event number
- 99774
- Firm
- Cadwell Industries Inc
- Firm FEI
- 3020018
- Product code
- GWF
- Status
- Open, Classified
- Initiated
- 2026-08-18
- Posted
- 2026-10-09
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K162199, K883340, K992911, K912685, K863175, K190703, K884870, K010087, K903731, K860903, K112052, K843253, K162873, K950208, K991899, K071821, K971740, K811848, K870567, K900482, K810482, K992313, K001101, K082614, K212166, K860240, K822744, K831896, K912775, K010090
Product#
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
Reason for Recall#
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.