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Neurosign V4

Technomed Engineering B.V. · Model 5885-00 · UDI-DI 08718375869505

GXZ Prescription

510(k) clearances

329

Adverse events

Recalls

Facilities

Description

Disposable Bipolar Probe 2 x 100mm x 0.75mm electrodes; 1.9m wire with DIN42802 connectors

Recalls

Date	Firm	Reason
2021-12-08	Technomed Europe	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.