ATLAS Stim Headbox-NK For use only with the ATLAS recall
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to…
Why was ATLAS Stim Headbox-NK For use only with the ATLAS 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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);
- Product
- ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to…
- Recalling firm
- Neuralynx Inc
- Quantity
- 15
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)