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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4

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 Class 2 Recall
Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4
see related information
Date Posted April 25, 2012
Recall Status1 Terminated on March 05, 2014
Recall Number Z-1454-2012
Recall Event ID 61482
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Code Information Vista software version 3.4
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Robert J. King
800-441-9250
Manufacturer Reason
for Recall
Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Siemens sent an Urgent Field Safety Notice dated December 19, 2011 to all affected customers alerting them to Invalid Below Manufacturer Assay Range Flags on Dimension Vista(R) Systems with Software Version 3.4. The UFSN included instructions on how to correct the situation and also included an effectiveness check form to be faxed to the firm at 302-631-8467. On January 16, 2012, the firm issued an additional UFSN alerting consignees to Invalid Above and Below Manufacturer Assay Range Flags. This notice also included directions and a Field Correction Effectiveness Check form to be completed and faxed to 302-631-8467. For technical questions customers were instruced to call 800-441-9250. For questions regarding this recall call 302-631-6299.
Quantity in Commerce 1,683
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland & Baltics, France, Germany, Italy, Japan, South Korea, Malaysia, Netherlands, New Zealand, Norway, Portugal, Puerto Rico, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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