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Vital Signs

Carefusion Finland 320 Oy · Model 7000AAO · UDI-DI 10885403248962

HGP Prescription

510(k) clearances

279

Adverse events (7 deaths)

Recalls

Facilities

Description

Fetal Spiral Electrode For Corometrics

Recalls

Date	Firm	Reason
2022-11-21	Philips North America Llc	Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decide
2019-01-25	Philips North America, LLC	During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
2012-10-16	Vital Signs Devices, a GE Healthcare Company	Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.

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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.