FDA recall Z-2992-2018

Hitachi Healthcare Americas Corp Informatics Division · Class II · device

Product

VidiStar(TM) PACS & DICOM Viewer Software system

Reason for recall

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.

Distribution

SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

Key facts

Status: Terminated
Initiation date: 2018-08-28
Report date: 2018-09-12
Termination date: 2021-02-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2992-2018