Neuralynx recalls unapproved ATLAS Stim Headboxes for research use only. These devices lack FDA clearance and electrical safety testing, posing potential risks. Affected units include specific serial numbers.
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.
Neuralynx is recalling ATLAS Stim Headboxes that were sold under an investigational device exemption (IDE) for research use only. The devices have not received FDA approval and lack electrical safety testing, which could pose risks if used outside their intended purpose.
The headboxes were delivered to US customers under a premise that they had an investigational device exemption (IDE) for research use only. However, the manufacturer does not have an approved IDE by the FDA, and the devices have not undergone electrical safety testing or received regulatory clearance. This means they could pose risks if used outside their intended research purpose.
Researchers using the ATLAS Neurophysiology System with these headboxes are most at risk. The recall applies to specific serial numbers sold under an investigational device exemption.
Check for serial numbers SN0001 through SN0012 on the ATLAS Stim Headbox-NK. These units were sold under an investigational device exemption for research use only.
Look for serial numbers SN0001 through SN0012 on the ATLAS Stim Headbox-NK.
The ATLAS Stim Headboxes were delivered to US customers under an investigational device exemption (IDE) for research use only, but the manufacturer does not have an approved IDE by the FDA and the devices have not undergone electrical safety testing or received regulatory clearance.
The official recall notice does not specify a remedy or action steps beyond checking serial numbers.
The recall indicates the devices lack FDA approval and electrical safety testing, so they are not safe for use outside their intended research purpose.
We’ve drafted a message you can send Neuralynx to request your refund or repair — edit it as you like.
Subject: Recall Z-1091-2022 — Neuralynx Neuralynx Hello, I own a Neuralynx that is covered by recall Z-1091-2022 from Neuralynx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
