24
Aug
2016

Cl II Merge Unity Z3D software

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/24/2016
Class lI:

PRODUCT

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications , and media interchange of medical images from a variety of diagnostic imaging systems.
Recall Number Z-2551-2016

REASON
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 7/23/2015. Voluntary: Firm Initiated recall is ongoing.

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

DISTRIBUTION
US Distribution to states of: CA, PA, TX, and MT.

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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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