Cadwell IOMAX Cortical Module Recalled for Defective Circuit Board
Cadwell Industries is recalling 23 IOMAX Cortical Modules because a defective circuit board may cause unintended electrical stimulation to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II, and the source describes a hazard where the device may deliver unintended electrical stimulation or current to a patient. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Cadwell Industries Inc is recalling 23 units of the IOMAX Cortical Module (Model/Catalog Number 190296-200). The affected devices are identified by specific serial numbers listed in the recall notice.
The recall is due to a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient or allow an unintended electrical current to reach the patient. The IOMAX Cortical Module is a component of the IOMAX system that contains various stimulators and amplifiers.
The affected devices were distributed worldwide, including in the United States (specifically Tennessee) and in Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland. Users should contact Cadwell Industries for instructions on how to address the defect.
The recalled product
- Product
- Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and…
- Manufacturer
- Cadwell Industries Inc
- Affected units
- 23
Distribution
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