FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Check against the official notice below — it lists the full affected range.
Edwards Lifesciences is recalling 402 units of the FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) worldwide. The device may display inaccurately low oxygen saturation (StO2) values when using the large sensor on arms and legs, though the directional trend of the readings remains accurate. These falsely low readings could lead to unintended or inappropriate medical treatment.
The recall affects all serial numbers of this model that were distributed nationwide across the United States and internationally to multiple countries including Canada, Australia, Brazil, and Argentina. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 402 units Lot/code info: FORE-SIGHT ELITE Tissue Oximeter, Model Number 01-06-3000, UDI: 10609538630009; All Serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.