Neurosign V4Recalls & reported problems across all models
Technomed Engineering B.V. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Neurosign V4 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of Neurosign V4 by Technomed Engineering B.V. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2019 and Jun 30, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Analyze Signal” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Neurosign V4 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 25, 2024Open, Classified
Product has have presence of brown discoloration or substance on the hinge area of the device
Z-3131-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Neurosign V4 problems
Device problems
- Failure to Analyze Signal1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Neurosign V4 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Neurosign V4 5888-00Electrode, Needle1 recall0 reports
- Neurosign V4 3601-00-TEElectrode, Needle1 report
- Neurosign V4 1699-00-TEElectrode, Needle1 report
Recent Neurosign V4 adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 30, 2023Fracture; Fracture
THE METAL PORTION OF THE NEEDLE ELECTRODE BROKE OFF IN THE PATIENT AND HAD TO BE CUT OUT. A SCOLIOSIS CORRECTION WAS BEING PERFORMED. ALL NEEDLE ELECTRODES, GROUNDS, CORKSCREWS AND ADHESIVE ELECTRODE PLACED AS USUAL AND PROCEDURE COMMENCED. NOTHING UNUSUAL TO REPORT DURING THE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTICED ONE NEEDLE WAS MISSING, AN X-RAY WAS TAKEN AND THE NEEDLE FOUND IN THE PATIENT, AT THE KNEE. THE NEEDLE WAS CUT OUT TO BE REMOVED. THE PATIENT IS DOING FINE. THERE WAS NO CHANGE IN SURGICAL OUTCOME AND NO IMPACT ON PATIENT HEALTH. THE NEEDLE COULD EASILY BE FOUND AND THE CUT MADE WAS DESCRIBED AS VERY SMALL. A SMALL PLASTER AND FEW STITCHES WERE USED TO CLOSE THE WOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17235379 ↗MalfunctionNov 27, 2019Failure to Analyze Signal; Failure to Analyze Signal
DURING PAROTIDECTOMY SURGERY, SURGEONS DETECTED A NERVE THEMSELVES WHICH WAS NOT PICKED UP BY THE DEVICE (PROBE) USED. USING ANOTHER PROBE, THE NERVE WAS DETECTED. SURGEONS CONCLUDED THE DEVICE MAY HAVE MALFUNCTIONED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9381013 ↗
Other Technomed Engineering B.V. products
All Technomed Engineering B.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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