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Recall Observatory FDA recall evidence

Device 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.

Z-1091-2022

March 14, 2022

Class II

Product summary

Firm
Neuralynx Inc
Event
Event 89843
Status
Ongoing
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-1091-2022

Official wording

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.

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);

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.