Recall Z-1091-2022— Neuralynx Inc
Class II · Ongoing
Class II FDA medical device recall by Neuralynx Inc, initiated 2022-03-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Neuralynx Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-14
- Firm location
- Bozeman, MT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.