Recall Z-1193-2019 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Edwards Lifesciences, LLC
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).
| Date | May 21, 2019 (initiated Mar 21, 2019) |
| Status | Terminated |
| Reason | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. |
| Root cause | Use error |
| Action | On 03/21/19, Urgent Medical Device Safety Notification - Action Required notices were mailed to consignees. The firm strongly advised that consignees be cautious that IV bags and other fluids need to be positioned away from AC power connectors in order to avoid liquid ingress. In addition, consignees were asked to follow installation instructions in the operator's manual and to complete and return the response form. On 03/30/19, Urgent Medical Device Safety Notification - Action Required Addendum was mailed informing customers that if they require assistance they may call Technical Support |
| Quantity | 22443 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform Edwards Lifesciences, LLC, Jun 1, 2016 |