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U.S. Department of Health and Human Services

Class 2 Device Recall EasyLink Informatics System included with the Dimension Vista System

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 Class 2 Device Recall EasyLink Informatics System included with the Dimension Vista Systemsee related information
Date Initiated by FirmJuly 14, 2009
Date PostedSeptember 29, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall NumberZ-1991-2009
Recall Event ID 52861
510(K)NumberK051087 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductEasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated 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.
Code Information Part Number: 1000046623.
FEI Number 2517506
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactTechnical Solutions Center
800-441-9250
Manufacturer Reason
for Recall		incorrect results may be transmitted to LIS
FDA Determined
Cause 2		Software design
ActionSiemens issued an "Urgent Device Correction" letter dated July 2009. The letter informed the user of the affected product including instructions for avoiding the problem. For further information, contact Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
Quantity in Commerce359 units
DistributionWorldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JJE
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