Cascade IOMAX Cortical Module, REF: 190296-200
FDA device recall Z-2349-2024 · posted 2024-07-12 · Open, Classified
Recall details
- Recalling firm
- Cadwell Industries Inc
- Reason for recall
- Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Action taken
- 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 replacement form.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- GWF
- Quantity affected
- 26 units
- Distribution
- US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
- Date initiated
- 2024-05-17
- Date posted
- 2024-07-12
- Location
- Kennewick, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cascade IOMAX Intraoperative Monitor (K162199) | Cadwell Industries, Inc. | 2017-03-02 |