Cl II Edwards Hemosphere System

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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