Cl II Siemens Dimension Vista Systems

Company:Siemens Healthcare Diagnostics, Inc
Date of Enforcement Report: 7/15/2015
Class lI:

PRODUCT

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Recall Number Z-2054-2015

REASON
there is the potential for two software issues to occur in Vista software versions 3.6.1 Issue #1 :Samples stop processing without notification for Dimension Vista instruments running software version 3.6.1. Issue#2:The Dimension Vista 1500 causing a series of unflagged, unexpected low results and complaints of results flagged with assay errors.

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 5/21/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2315

DISTRIBUTION
Nationwide and Internationally

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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.

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