Z-1091-2022Class II

ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE...

Name: Z-1091-2022 ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE...
Creator: Neuralynx Inc
Published: 2022-03-14
License: https://open.fda.gov/license/

Neuralynx, Inc. / initiated 2022-03-14 / Open, Classified / root cause: manufacturing process

FDA source

Neuralynx Inc began a recall of ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to... on 2022-03-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1091-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-14
Posted: 2022-05-13
Recalling firm: Neuralynx, Inc.
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.
Product code: GXY Electrode, Cutaneous
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1091-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1091-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code GXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)