FDA-Device2015-06-17Class II
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Edwards Lifesciences, LLC
Hazard
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.
Affected count
1,309 units total (696 units in US)
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2015Don't want to check this manually?
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