VidiStar — Class II medical device recall Z-2992-2018
Terminated recall by Hitachi Healthcare Americas Corp Informatics Division, reported 2018-09-12, distributed in AZ, CO, GA, IL, IN, MA, MT, OH…. The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may ca
| Recall number | Z-2992-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Healthcare Americas Corp Informatics Division, Greenville, SC, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2021-02-11 |
| Distributed | AZ, CO, GA, IL, IN, MA, MT, OH, SC, TX |
| Quantity | 12 units |
| Reason classes | software |
Product
VidiStar(TM) PACS & DICOM Viewer Software system
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2992-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.