19
Apr
2017

iConnect Enterprise Archive (ICEA) software Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/19/2017
Class lI:

PRODUCT

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Recall Number Z-1762-2017

REASON
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

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

VOLUME OF PRODUCT IN COMMERCE
333 sites potentially have the affected accessory

DISTRIBUTION
Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.

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About the author

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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