Edwards Lifesciences, LLC: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Is my product affected?

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

• UPC 00690103208573

Check against the official notice below — it lists the full affected range.

What happened

Edwards Lifesciences is recalling the FORE-SIGHT ELITE Tissue Oximeter Module (model HEMFSM10) because the device may display inaccurately low oxygen saturation (StO2) values when used with the Fore-Sight Elite large sensor on the arms and legs. While the directional trend of the readings remains accurate, the absolute values can be significantly lower than actual levels, which could potentially lead to unintended or inappropriate treatment decisions. Approximately 8,389 units have been distributed worldwide, including throughout the United States.

The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, CANARY ISLANDS, Colombia, Co Quantity: 8389 units Lot/code info: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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