Mar

2017

Merge iConnect Enterprise Archive Cl II

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

PRODUCT

iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare
Recall Number Z-1470-2017

REASON
The software produced a number of ”do not route” exceptions, which may result in potential patient injury or delay in diagnosis or treatment..

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

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

DISTRIBUTION
USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

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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 Enterprise Archive Cl II

Amy Sellers

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