Merge PACS software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/14/2016
Class lI:

PRODUCT

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
Recall Number Z-0726-2017

REASON
Cut lines on the image may present horizontally rather than vertically..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 3/28/2016. Voluntary: Firm Initiated recall is ongoing.

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

DISTRIBUTION
Nationwide and Internationally

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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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