Aug

2016

Cl II Merge HEMO software

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/10/2016
Class lI:

PRODUCT

Merge HEMO software
Recall Number Z-2341-2016

REASON
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. Hartland, WI on 7/2/2012 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
37

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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Cl II Merge HEMO software

Amy Sellers

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