Company:Edwards Lifesciences, LLC
Date of Enforcement Report 27/2018
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
Pre-procedural issues related to software defects.
Edwards Lifesciences, LLC, Irvine, CA on 10/2/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE