EV1000 Clinical Platform recalled over fire hazard

Recall date

March 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edwards Lifesciences, LLC recalls EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid…

Recall number

Z-1193-2019

FDA classification

Class I

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR. Foreign (OUS): IT, FI, CO, KR, JP, PL, BE, GR, NL, IL,…

Why it was recalled

Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).