FDAJuly 23, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
What to do
FDA enforcement status: Terminated
Brands named
merge healthcaremerge
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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