Recall Z-1732-2015 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Edwards Lifesciences, LLC
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
| Date | Jun 9, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| Reason | Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. |
| Root cause | 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 | 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 Afric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140312 | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM Edwards Lifesciences, LLC, Jun 13, 2014 |