Medical device recalls Moderate risk

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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