Recall Z-0835-2022— Edwards Lifesciences, LLC
Class II · Ongoing
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2022-03-01. It names 2 FDA 510(k) clearances: K201446, K180003. Product: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10. Reason: 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.
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-01
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K201446 — HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
- K180003 — FORE-SIGHT ELITE Module Tissue Oximeter
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.