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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