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U.S. Department of Health and Human Services

Class 2 Device Recall ClearSight System

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  Class 2 Device Recall ClearSight System see related information
Date Initiated by Firm May 18, 2015
Date Posted June 09, 2015
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-1732-2015
Recall Event ID 71246
510(K)Number K140312  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Code Information All serial numbers. From 600104000221 to 600104005025
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-2500
Manufacturer Reason
for Recall		 Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
FDA Determined
Cause 2		 Device Design
Action Edwards Lifesciences sent an URGENT Product Notification letter dated May 12, 2015, to all affected customers. The letter informed customers that Edwards Lifesciences has received reports that a component of the ClearSight System can be damaged if not handled properly. The letter informs customers of the problems identified and the actions to be taken. Customers with questions are instructed to call Edwards Technical Support. For questions regarding this recall call 949-250-2500.
Quantity in Commerce 1,309 units total (696 units in US)
Distribution 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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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