Recall – PACS & DICOM Viewer Software system

Company: Hitachi Healthcare Americas Corp Informatics Division.
Date of Enforcement Report 9/12/2018
Class II:

PRODUCT
VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Hitachi Healthcare Americas Corp Informatics Division, Greenville, NC on 8/28/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12

DISTRIBUTION
DSC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

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Partners located in the US (CA, FL, MA, MN) and Italy.