Recall Z-1193-2019— Edwards Lifesciences, LLC

Name: FDA recall Z-1193-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-21

Class I · Terminated

Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2019-03-21, terminated 2023-11-28. It names one FDA 510(k) clearance: K160552. Product: 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).. Reason: Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class I
Status: Terminated
Initiated: 2019-03-21
Terminated: 2023-11-28
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC·cleared 2016-06-01

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

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.