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.

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.

Customer notifications were sent out to all affected customers on March 14, 2022, via USPS certified mail. Actions to be taken: Field representatives will be contacting consignees to return the effected product and coordinate a replacement with their cleared headbox, product models 31-0601-0007, 31-0601-0010 or 31-0601-0017, by April 6, 2022. In the interim, it is advised to stop use of this product. Any further questions regarding this matter, contact by email at [email protected] or by telephone at 207-666-5425 Monday -Friday 8:00 AM -4:30 PM EST.