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Class 2 Device Recall EasyLink Informatics System included with the Dimension Vista System |
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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
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Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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
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For Additional Information Contact |
Technical Solutions Center 800-441-9250
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Manufacturer Reason for Recall |
incorrect results may be transmitted to LIS
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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
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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