Contact Gel
SenTec AG · Model GEL-04 · UDI-DI 07640121880070
4
510(k) clearances
115
Adverse events (4 deaths)
12
Recalls
56
Facilities
Description
The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
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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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.