Class 2 Device Recall VidiStar(TM) PACS & DICOM Viewer Software system

• Date Initiated by Firm: August 28, 2018
• Create Date: September 06, 2018
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-2992-2018
• Recall Event ID: 80896
• 510(K)Number: K083910
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: VidiStar(TM) PACS & DICOM Viewer Software system
• Code Information: versions 3.10.5 and 3.10.6
• Recalling Firm/ Manufacturer: Hitachi Healthcare Americas Corp Informatics Division; 204 Westfield St; Greenville SC 29601-1833
• For Additional Information Contact: Support Department ; 888-518-7541 Ext. 1
• Manufacturer 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.
• FDA Determined Cause: Software in the Use Environment
• Action: The firm initiated the recall by email on 08/28/2018. The firm will be removing the 3rd party software from the interface and replacing it with new software and notify the affected customers when the action is completed.
• Quantity in Commerce: 12 units
• Distribution: SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQK