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U.S. Department of Health and Human Services

Class 2 Device Recall ATLAS Stim Headbox

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  Class 2 Device Recall ATLAS Stim Headbox see related information
Date Initiated by Firm March 14, 2022
Create Date May 13, 2022
Recall Status1 Open3, Classified
Recall Number Z-1091-2022
Recall Event ID 89843
Product Classification Electrode, cutaneous - Product Code GXY
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.
Code Information ASHB Part No. 31-0601-0077 (SN0001, SN0002, SN0004, SN0005, SN0006, SN0007, SN0008, SN0009, SN0010, SN0012); ASHB Part No. 31-0601-0132(SN0003, SN0005, SN0006); ASHB Part No. 31-0601-0089(SN0004, SN0006);
Recalling Firm/
Manufacturer		 Neuralynx Inc
105 Commercial Dr
Bozeman MT 59715
For Additional Information Contact Kelly Moeykens
207-666-5651 Ext. 2195
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 No Marketing Application
Action 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 kmoeykens@fh-co.com or by telephone at 207-666-5425 Monday -Friday 8:00 AM -4:30 PM EST.
Quantity in Commerce 15
Distribution U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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