Z-2992-2018Class II

VidiStar(TM) PACS & DICOM Viewer Software system

Name: Z-2992-2018 VidiStar(TM) PACS & DICOM Viewer Software system
Creator: Hitachi Healthcare Americas Corp Informatics Division
Published: 2018-08-28
License: https://open.fda.gov/license/

Hitachi Healthcare Americas Corp Informatics Division / initiated 2018-08-28 / Terminated / root cause: software

FDA source

Hitachi Healthcare Americas Corp Informatics Division began a recall of VidiStar(TM) PACS & DICOM Viewer Software system on 2018-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2992-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-28
Posted: 2018-09-06
Terminated: 2021-02-11
Recalling firm: Hitachi Healthcare Americas Corp Informatics Division
Product: VidiStar(TM) PACS & DICOM Viewer Software system
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root 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
Product codes and lots: versions 3.10.5 and 3.10.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2992-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2992-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06

Product code DQK

K083910Class IIVidistar Pacs & Dicom Viewer Software Server Software System, Heart View, Standalone ViewerVidistar, LLC / cleared 2009-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)