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ROCKET MEDICAL PLC · Model R57008-00-FM · UDI-DI 05055270977113
1
510(k) clearances
279
Adverse events (7 deaths)
3
Recalls
20
Facilities
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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Get your free API keyRead the docsData 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.