FDA Device recall Z-2992-2018
VidiStar(TM) PACS & DICOM Viewer Software system
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of VidiStar(TM) PACS & DICOM Viewer Software system by Hitachi Healthcare Americas Informatics Division, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2992-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-28 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hitachi Healthcare Americas Informatics Division |
| Distribution | AZ, CO, GA, IL, IN, MA, MT, OH, SC, TX |
Product
VidiStar(TM) PACS & DICOM Viewer Software system
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.
Identifiers
| code_info | versions 3.10.5 and 3.10.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2992-2018%22
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