medical Class II Updated 2022-05-25

Neuralynx Inc recalls ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysi

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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);

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