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Neuralynx Inc recalls ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Fed
Recalled May 25, 2022 · FDA recall Z-1091-2022 · Neuralynx
Hazard
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance. · FDA Class II
Units
15
Sold at
U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.
Description
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
Product
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Manufacturer(s)
Neuralynx Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →