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HemoSphere Tissue Oximetry Module
Edwards Lifesciences LLC · Model HEMTOM10 · UDI-DI 00690103200355
10
510(k) clearances
706
Adverse events (6 deaths)
6
Recalls
58
Facilities
Description
HemoSphere Tissue Oximetry Module
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-09 | Covidien | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2024-01-09 | Covidien | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2023-10-30 | KENT IMAGING, INC. | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. |
| 2022-03-01 | Edwards Lifesciences, LLC | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight E |
| 2022-03-01 | Edwards Lifesciences, LLC | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight E |
| 2009-10-23 | Nonin Medical, Inc | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the |
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