Cascade IOMAX Cortical Module, REF: 190296-200
FDA device recall Z-1882-2024 · posted 2024-05-22 · Open, Classified
Recall details
- Recalling firm
- Cadwell Industries Inc
- Reason for recall
- 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.
- Action taken
- 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 the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- GWF
- Quantity affected
- 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.
- Date initiated
- 2024-04-23
- Date posted
- 2024-05-22
- Location
- Kennewick, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cascade IOMAX Intraoperative Monitor (K162199) | Cadwell Industries, Inc. | 2017-03-02 |