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Edwards Lifesciences, LLC Recall 89647

Description: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Edwards Lifesciences, LLC Recall 89647 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0835-2022
Event ID89647
Event DescriptionFORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Product TypeDevices
DistributionWorldwide 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, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Northern Ireland, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Vietnam.
Quantity8389 units
Recall ReasonThe 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
Device Classification20220406
Device Code InfoFORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.
Center Classification Date20220330
Recall Initiation Date20220301
Recalling FirmEdwards Lifesciences, LLC
Initial Notification Letter
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