Nov

2016

Merge PACS software. Cl II

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

PRODUCT

Merge PACS software. Product Usage: 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-0599-2017

REASON
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/16/2016. Voluntary: Firm Initiated recall is ongoing.

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

DISTRIBUTION
Nationwide and Canada

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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 PACS software. Cl II

Amy Sellers

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