• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VidiStar(TM) PACS & DICOM Viewer Software systemsee related information
Date Initiated by FirmAugust 28, 2018
Create DateSeptember 06, 2018
Recall Status1 Terminated 3 on February 11, 2021
Recall NumberZ-2992-2018
Recall Event ID 80896
510(K)NumberK083910 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductVidiStar(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 ContactSupport 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
ActionThe 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 Commerce12 units
DistributionSC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQK
-
-