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U.S. Department of Health and Human Services

Class 1 Device Recall EV1000 Clinical Platform

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  Class 1 Device Recall EV1000 Clinical Platform see related information
Date Initiated by Firm March 21, 2019
Create Date May 21, 2019
Recall Status1 Open3, Classified
Recall Number Z-1193-2019
Recall Event ID 82456
510(K)Number K160552  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
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).
Code Information All lots
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-6827
Manufacturer Reason
for Recall
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
FDA Determined
Cause 2
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 is 800-822-9837.
Quantity in Commerce 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, AT, DK,CA, GB, BR, SA, SE, DE, AU, FR, MX, IN, IC, ZA, ES, TR, NZ, MY, IE, SG, CZ, SI, PT, CH, RE, LK, CR, AR, HK, NO, PY, PA, MT, EG, NP, TN, RU, RO, NA,CL, BH, IR, PH, TH, KZ, DZ, BG, EE, KW, VN, OM, PE, EC, AE, MA, VE, BO, QA, DO, GT, BY, JO, LT, SK, HU, CY, MN, TW, CN
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = EDWARDS LIFESCIENCES, LLC
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