Nov

2016

Merge iConnect Access software. Cl II

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

PRODUCT

MergeMerge LIS software
Recall Number Z-0611-2017

REASON
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/17/2016. Voluntary: Firm Initiated recall is ongoing.

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

DISTRIBUTION
Sites Nationwide and internationally

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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 iConnect Access software. Cl II

Amy Sellers

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