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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 Recall
EasyLink Informatics System included with the Dimension Vista System
see related information
Date Posted September 29, 2009
Recall Status1 Terminated on January 05, 2010
Recall Number Z-1991-2009
Recall Event ID 52861
Premarket Notification
510(K) Numbers
K012702  K842234  K904870  K904880  K960425 
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, Delaware 19714-6101
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 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 = ENDOMEDICS, INC.
510(K)s with Product Code = JJE and Original Applicant = ENDOTEC, INC.
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