Mar

2017

Merge Hemo software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/22/2017
Class lI:

PRODUCT

Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Recall Number Z-1457-2017

REASON
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
361 sites potentially have the affected versions

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

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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Merge Hemo software Cl II

Amy Sellers

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