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Merge Healthcare, Inc. recalls Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management s
Recalled August 24, 2016 · FDA recall Z-2551-2016 · Merge Healthcare
Hazard
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. · FDA Class II
Units
9 sites potentially have the affected version
Sold at
US Distribution to states of: CA, PA, TX, and MT.
Description
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
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.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →