Cadwell Industries Inc Recall 94764
Description: Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries Inc Recall 94764 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2349-2024 |
| Event ID | 94764 |
| Event Description | Cascade IOMAX Cortical Module, REF: 190296-200 |
| Product Type | Devices |
| Distribution | US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom |
| Quantity | 26 units |
| Recall 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. |
| Device Classification | 20240724 |
| Device Code Info | UDI: 00840067100653/Serial Numbers:19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004,19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, 19029603AA0524004 |
| Center Classification Date | 20240712 |
| Recall Initiation Date | 20240517 |
| Recalling Firm | Cadwell Industries Inc |
| Initial Notification | Letter |
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