FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
UPCs
Recall history
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