Oximeter, Tissue Saturation
FDA adverse event reports and recall history for oximeter, tissue saturation (product code MUD), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 744
- Deaths
- 6
- Injuries
- 55
- Malfunctions
- 671
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-21Open, ClassifiedLabeling mix-ups
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
- 2024-04-30Open, ClassifiedProcess design
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
- 2024-04-30Open, ClassifiedProcess design
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
- 2024-01-25Open, ClassifiedNonconforming Material/Component
Snapshot NIR, REF: KD204
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
- 2009-11-25TerminatedDevice Design
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
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 potential to cause a burn if the POD is in direct contact with the patient.
- Open, ClassifiedSoftware in the Use Environment
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
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 Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
- Open, ClassifiedSoftware in the Use Environment
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
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 Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
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