Recall – VidiStar(TM) PACS & DICOM Viewer SW system Cl II

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

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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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