Membrane Changer (single-use) / single unit
SenTec AG · Model MC · UDI-DI 07640121880933
4
510(k) clearances
114
Adverse events (4 deaths)
12
Recalls
56
Facilities
Description
The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.
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.