Neurosign V4 recallZ-3131-2024 · Technomed Europe · initiated Jul 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Technomed Europe or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product has have presence of brown discoloration or substance on the hinge area of the device
FDA root cause category: Process control
What the company is doing
Technomed Europe issued a FIELD SAFETY NOTICE to its consignees on 07/25/2024 via email. The notice explained the issue, potential risk, and requested the cessation of distribution and quarantine of the affected product pending return of the affected product. Distributors were directed to notify those to whom the product was distributed by forwarding a copy of the notice.
Recall details
- Recall number
- Z-3131-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 25, 2024
- Posted by the FDA
- Sep 12, 2024
- Recalling firm
- Technomed Europe
- Quantity
- 71 units
- Product code
- ETN
- FDA submissions
- K110422
- Distribution
- US: FL, CA, TX, IL, NY, PA, MA
Product description
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Code information (models, lots, serial numbers)
UDI/DI 08718375869659, Lot Numbers: 061158, 061380
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neurosign V4 5888-00Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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