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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall VidiStar(TM) PACS & DICOM Viewer Software system see related information
Date Initiated by Firm August 28, 2018
Create Date September 06, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = VIDISTAR, LLC
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