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Terminated

VidiStar(TM) PACS & DICOM Viewer Software system

FDA Recall Z-2992-2018 · Posted None

Recalling FirmHitachi Healthcare Americas Corp Informatics Division
Recall StatusTerminated
Product CodeDQK
Date Initiated2018-08-28
Date Terminated2021-02-11
Product Quantity12 units

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.

Firm 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.

Root Cause

Software in the Use Environment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083910VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWERVidistar, LLC · 2009-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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