Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VidiStar(TM) PACS & DICOM Viewer Software system Recalled by Hitachi Healthcare Americas Corp Informatics Division Due to The secure filesystem client software used in the...

Date: August 28, 2018
Company: Hitachi Healthcare Americas Corp Informatics Division
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Healthcare Americas Corp Informatics Division directly.

Affected Products

VidiStar(TM) PACS & DICOM Viewer Software system

Quantity: 12 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 10 states: AZ, CO, GA, IL, IN, MA, MT, OH, SC, TX

Affected (10 states)Not affected

About Hitachi Healthcare Americas Corp Informatics Division

Hitachi Healthcare Americas Corp Informatics Division has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report