Recall Z-2349-2024 ยท GWF Stimulator, Electrical, Evoked Response
Cadwell Industries Inc
Cascade IOMAX Cortical Module, REF: 190296-200
| Date | Jul 12, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation. |
| Root cause | Process design |
| Action | On 5/17/2024, Cadwell Industries, Inc. issued "Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Cadwell ask consignees to take the following actions: 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. Please complete acknowledgement and product |
| Quantity | 26 units |
| Distribution | US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, 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 |