ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvas
FDA device recall Z-1732-2015 · posted 2015-06-09 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 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,
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-09
- Date terminated
- 2015-11-06
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM (K140312) | Edwards Lifesciences, LLC | 2014-06-13 |