Device product

VidiStar(TM) PACS & DICOM Viewer Software system

Z-2992-2018

August 28, 2018

Class II

Product summary

Firm: Hitachi Healthcare Americas Corp Informatics Division
Event: Event 80896
Status: Terminated
Classification: Class II
Quantity: 12 units
Official record key: device-enforcement:Z-2992-2018

Official wording

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.

Code information: versions 3.10.5 and 3.10.6

Distribution pattern: SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software used in the interface between the Vidistar PACS and an EHR system may cause