Edwards Lifesciences, LLC recalls FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Recalled Product
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Hazard / Issue
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
Issued by
FDA
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