Recall Z-0141-2027 ยท GWF Stimulator, Electrical, Evoked Response
Cadwell Industries Inc
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
| Date | Oct 9, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 08/18/2026, an "URGENT: MEDICAL DEVICE RECALL" Letter was emailed informing customers that, a manufacturing defect was identified in a limited number of IOMAX Cortical Modules. Following a recent change in printed circuit board assembly (PCBA) vendor, the defect was discovered during routine production processes on a limited number of PCBA s that were used in IOMAX Cortical Modules. The identified risk is specific to the Cortical Module and Cascade Surgical Studio (CSS). However, because Cortical Modules can be used with Zenith, Arc, and CSS, a module currently in use with Zenith or Arc cou |
| Quantity | 23 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162199 | Cascade IOMAX Intraoperative Monitor Cadwell Industries, Inc., Mar 2, 2017 |