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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 System see related information
Date Initiated by Firm July 14, 2009
Date Posted September 29, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall Number Z-1991-2009
Recall Event ID 52861
510(K)Number K051087  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product EasyLink 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.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall		 incorrect results may be transmitted to LIS
FDA Determined
Cause 2		 Software design
Action Siemens 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 Commerce 359 units
Distribution Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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