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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 System

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 Class 2 Recall
Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 System
see related information
Date Posted January 28, 2014
Recall Status1 Open
Recall Number Z-0851-2014
Recall Event ID 66585
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 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 Material numbers 10284473, 10488224, 10444801, and 10444802.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall
When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software in the Use Environment
Action Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring: 1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide. 2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing. 3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.
Quantity in Commerce 2038
Distribution USA (nationwide) Distribution including Puerto Rico.
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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