Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0835-2022 — FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

U.S. FDA — Device Enforcement · United States · 2022-03-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0835-2022
Date of alert
2022-03-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00690103208573
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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