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

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.