FDAAugust 28, 2018device

VidiStar(TM) PACS & DICOM Viewer Software system

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

hitachi healthcare americas corp informatics divisionhitachihitachi healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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