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Class 2 Device Recall ClearSight System |
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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
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Product Classification |
System, measurement, blood-pressure, non-invasive - Product Code DXN
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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
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For Additional Information Contact |
949-250-2500
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Manufacturer Reason for Recall |
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DXN and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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