Cascade IOMAX Cortical Module recall
Cascade IOMAX Cortical Module, REF: 190296-200
Why was Cascade IOMAX Cortical Module 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Cascade IOMAX Cortical Module, REF: 190296-200
- Recalling firm
- Cadwell Industries Inc
- Quantity
- 26 units
- Distribution
- US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)