FDAMarch 14, 2022device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
neuralynx
Recall history
No related federal recalls on record for this brand yet.
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