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Neonatal Starter Set (without Service Gas)

SenTec AG · Model SSET-N_nG · UDI-DI 07640121880445

DPZ DQA KLK LKD LPP Prescription

510(k) clearances

114

Adverse events (4 deaths)

Recalls

Facilities

Description

Neonatal Starter Set (without Service Gas) contains: Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) Service Gas (GAS-0812)

Recalls

Date	Firm	Reason
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19	GE Healthcare Finland Oy	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2011-04-08	GE Healthcare, LLC	The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for s

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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.