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103420 Sensor Adapter Cable (Regular)

SenTec AG · Model 103420 · UDI-DI 07640121881008

DPZDQAKLKLKDLPP Prescription
1
510(k) clearances
114
Adverse events (4 deaths)
12
Recalls
55
Facilities

Description

The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCOM+. The cable is available in different lengths: Regular, Long, Extra Long.

Recalls

DateFirmReason
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19GE Healthcare Finland OyThere is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2011-04-08GE Healthcare, LLCThe 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.