# FDA recall Z-2992-2018

> **Hitachi Healthcare Americas Corp Informatics Division** · Class II · device recall initiated 2018-08-28.

## 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.

## Distribution

SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

## Key facts

- **Recall number:** Z-2992-2018
- **Recalling firm:** Hitachi Healthcare Americas Corp Informatics Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-09-12
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2992-2018

## Citation

> AI Analytics. FDA recall Z-2992-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2992-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*