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