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Oximeter, Tissue Saturation
FDA product code MUD · Class 2 · Cardiovascular
221
Registered devices
744
Adverse events
7
Recalls
74
510(k) clearances
Devices with this code
CARESCAPE B450 — GE Healthcare Finland OyIntra.Ox Smart Sensor — VIOPTIX, INC.INVOS — Covidien LPINVOS — Covidien LPHemoSphere Vita — Edwards Lifesciences LLCINVOS — Covidien LPINVOS — Covidien LPINVOS — Covidien LPNonin — NONIN MEDICAL, INC.Component Neuromonitoring System — MOBERG RESEARCH INCHemoSphere — Edwards Lifesciences LLCINVOS — Covidien LPFORE-SIGHT ELITE® — CAS MEDICAL SYSTEMS, INC.HyperView — Hypermed Imaging, Inc.FORE-SIGHT® — CAS MEDICAL SYSTEMS, INC.Nonin — NONIN MEDICAL, INC.Viewfinder remote app — Edwards Lifesciences LLCFORE-SIGHT® — CAS MEDICAL SYSTEMS, INC.Component Neuromonitoring System — MOBERG RESEARCH INCHemoSphere Vita — Edwards Lifesciences LLCSpectros T-Stat — SPECTROS CORPORATIONINVOS — Covidien LPHemoSphere — Edwards Lifesciences LLCHemoSphere Vita — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-11 | Becton, Dickinson and Company | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. |
| 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 w |
| 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 w |
| 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 unlikel |
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