Cascade IOMAX Cortical Module, REF: 190296-200
Reported: May 29, 2024 Initiated: April 23, 2024 #Z-1882-2024
Product Description
Cascade IOMAX Cortical Module, REF: 190296-200
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.
Details
- Recalling Firm
- Cadwell Industries Inc
- Units 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.
- Location
- Kennewick, WA
Frequently Asked Questions
What product was recalled? ▼
Cascade IOMAX Cortical Module, REF: 190296-200. Recalled by Cadwell Industries Inc. Units affected: 54 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1882-2024.
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