Company:Edwards Lifesciences, LLC
Date of Enforcement Report 27/2018
Class lI:

PRODUCT

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables.
Recall Number Z-0496-2018

REASON
Pre-procedural issues related to software defects.

RECALLING FIRM/MANUFACTURER
Edwards Lifesciences, LLC, Irvine, CA on 10/2/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
198 devices

DISTRIBUTION
Nationwide

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