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TC pO2/pCO2 Membraning kit For TC electrode

Radiometer Medical ApS · Model 904-892 · UDI-DI 05700699048929

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510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

D280 Membraning kit For TC pO2/pCO2 electrode

Recalls

Date	Firm	Reason
2023-07-25	SenTec AG	During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement perform
2023-05-02	SenTec AG	The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
2022-08-22	SenTec AG	Weak skin adhesion.
2020-12-10	SenTec AG	Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
2020-02-20	Radiometer Medical ApS	Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitori
2019-05-02	SenTec AG	There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
2019-05-02	SenTec AG	There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
2019-05-02	SenTec AG	There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
2019-05-02	SenTec AG	There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
2019-05-02	SenTec AG	There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

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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.