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Membrane Changer Set

SenTec AG · Model MC-SET · UDI-DI 07640121880490

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510(k) clearances

114

Adverse events (4 deaths)

Recalls

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-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). The memrane changer set contains the MC-R and inserts (MC-I) to reload. Membrane Changer Set [1 membrane changer, 1 insert]

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.