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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