Cascade IOMAX Cortical Module recalled for potential electrical shock hazard
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
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: FDA Class II medical device with potential for electrical shock to patients. No injuries or illnesses have been reported. This is a risk-of-harm product where injury has not yet occurred, meeting the High severity threshold.
Plain-English summary
The Cascade IOMAX Cortical Module, manufactured by Cadwell Industries Inc, is being recalled by the FDA. This electroneurodiagnostic medical device is used in neurophysiological testing and evaluation.
The device's insulator may be installed incorrectly. If an insulator is incorrectly installed, electrical arcing could occur at patient connections, potentially resulting in unintended electrical shock to patients.
A total of 54 units have been distributed worldwide. Distribution includes Maryland in the United States and internationally to Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, the European Union, Switzerland, South Africa, Iraq, and the United Kingdom.
If you have one of the affected units, identified by the UDI-DI number 00840067100653, do not use the device. Contact Cadwell Industries Inc or your healthcare provider immediately.
The recalled product
- Product
- Cascade IOMAX Cortical Module, REF: 190296-200
- Manufacturer
- Cadwell Industries Inc
- Affected units
- 54
Distribution
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