Hitachi Healthcare Americas Corp Informatics Division recalls VidiStar(TM) PACS & DICOM Viewer Software system
- Recall date
- August 28, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2992-2018
- FDA classification
- Class II
- Brand / firm
- Hitachi Healthcare Americas Corp Informatics Division
- Sold / distributed
- SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
Why it was recalled
The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VidiStar(TM) PACS & DICOM Viewer Software system
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