Cascade IOMAX Cortical Module recalled for defective circuit board
Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a defective component that poses a risk of unintended electrical stimulation. No injuries or illnesses have been reported in the source material, which aligns with the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cadwell Industries Inc. is recalling the Cascade IOMAX Cortical Module, a medical device used for electroneurodiagnostic testing. The recall affects 26 units identified by specific serial numbers.
The recalled devices contain a defective printed circuit board that may damage other internal components, potentially resulting in unintended electrical stimulation during use.
The affected units were distributed in the United States (Illinois and California) and internationally to Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, and the United Kingdom.
Healthcare providers and facilities with affected devices should discontinue use immediately and contact Cadwell Industries Inc. for return or replacement instructions. Patients or clinicians with concerns should consult their healthcare provider.
The recalled product
- Product
- Cascade IOMAX Cortical Module, REF: 190296-200
- Manufacturer
- Cadwell Industries Inc
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: 00840067100653/Serial Numbers:19029603AA0224001
- 19029603AA0224002
- 19029603AA0224003
- 19029603AA0224004
- 19029603AA0224005
- 19029603AA0224006
- 19029603AA0224007
- 19029603AA0224008
- 19029603AA0224010
- 19029603AA0224021
- 19029603AA0224027
- 19029603AA0324006
- 19029603AA0324007
- 19029603AA0324008
- 19029603AA0324009
- 19029603AA0324010
- 19029603AA0424001
- 19029603AA0424002
- 19029603AA0424003
- 19029603AA0424006
Distribution
Related recalls
Same manufacturer · Cadwell Industries Inc
See all →- SevereCadwell IOMAX Cortical Module Recalled for Defective Circuit Board
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