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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01537-1
Product Name/Description	ClearSight Heart Reference Sensor Model Number: EVHRS All serial numbers manufactured after December 31, 2015 ARTG Number: 219809
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/12/2017
Responsible Entity	Edwards Lifesciences Pty Ltd
Reason/Issue	Edwards Lifesciences has been made aware of reports of “Out of Range” error messages for the Edwards ClearSight Heart Reference Sensor. An analysis of EVHRS Out of Range complaints led to the determination that the product is not meeting the current labelled shelf life (expiry date) of 730 days (2 years) from the date of manufacture. As a result, Edwards Lifesciences are amending the expiration date to six months from the date of manufacture. There have been no reported patient injuries as a result of this issue.
Recall Action	Recall
Recall Action Instructions	Edwards Lifesciences are advising customers that they will be in contact with affected users to arrange for replacement of the device. In the interim, if users do not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the HRS is functioning properly and patient monitoring is not adversely impacted. This action has been closed out on the 22/11/2018.
Contact Information	1800 222 601 - Edwards Technical Support