Home / Recalls / Neuralynx Inc / Z-1091-2022

Z-1091-2022 Class II Ongoing

Recalled by Neuralynx Inc — Bozeman, MT

Recall Details

Product Type: Devices
Report Date: May 25, 2022
Initiation Date: March 14, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15

Product Description

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.

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.

Distribution Pattern

U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.

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);