Nov

2016

Merge LIS software. Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 11/23/2016
Class lI:

PRODUCT

MergeMerge LIS software
Recall Number Z-0399-2017

REASON
There is a potential for duplicate container numbers to be created for patients..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/11/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
413 sites potentially have the affected software

DISTRIBUTION
Nationwide, the Virgin Islands and the Bahamas

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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 LIS software. Cl II

Amy Sellers

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