Recall Z-1882-2024 ยท GWF Stimulator, Electrical, Evoked Response
Cadwell Industries Inc
Cascade IOMAX Cortical Module, REF: 190296-200
| Date | May 22, 2024 (initiated Apr 23, 2024) |
| Status | Open, Classified |
| Reason | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient. |
| Root cause | Process design |
| Action | On 4/22/24, Cadwell Industries, Inc. issued a "Urgent: Medical Device Recall" notification to affected consignees via Email: 1. Cease use of the device immediately and return all identified devices to Cadwell Industries, Inc. 2. Please complete the attached response form and return via email to quality@cadwell.com. 3. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred the IOMAX Cortical Module to. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to t |
| Quantity | 54 units |
| Distribution | Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162199 | Cascade IOMAX Intraoperative Monitor Cadwell Industries, Inc., Mar 2, 2017 |