Oximeter, Tissue Saturation

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

Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Snapshot NIR, REF: KD204

Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Med

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.

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

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