Recall – PACS & DICOM Viewer Software system

Company: Hitachi Healthcare Americas Corp Informatics Division.
Date of Enforcement Report 9/12/2018
Class II:

PRODUCT
VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018

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.

RECALLING FIRM/MANUFACTURER
Hitachi Healthcare Americas Corp Informatics Division, Greenville, NC on 8/28/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12

DISTRIBUTION
DSC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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