Reported May 25, 2022 · Ongoing
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by…
Neuralynx Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neuralynx Inc · 105 Commercial Dr · Bozeman, MT · 59715
Is this the product you have?
- 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.
- Lot codes and dates
ASHB Part No. 31-0601-0077 (SN0001SN0002SN0004SN0005SN0006SN0007SN0008SN0009SN0010SN0012)ASHB Part No. 31-0601-0132(SN0003SN0005SN0006)ASHB Part No. 31-0601-0089(SN0004SN0006)
- Amount recalled
- 15
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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