Cascade IOMAX Cortical Module, REF: 190296-200
Reported: July 24, 2024 Initiated: May 17, 2024 #Z-2349-2024
Product Description
Cascade IOMAX Cortical Module, REF: 190296-200
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.
Details
- Recalling Firm
- Cadwell Industries Inc
- Units Affected
- 26 units
- Distribution
- US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, 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: 26 units.
Why was this product recalled? ▼
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2349-2024.
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