Device 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.
Z-1732-2015
Product summary
- Event
- Event 71246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,309 units total (696 units in US)
- Official record key
device-enforcement:Z-1732-2015
Official wording
Reason: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Code information: All serial numbers. From 600104000221 to 600104005025
Distribution pattern: 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.
Derived failure modes
-
Unknown
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.