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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare Diagnostics

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  Class 2 Device Recall Siemens Healthcare Diagnostics see related information
Date Initiated by Firm April 14, 2014
Date Posted June 09, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-1733-2014
Recall Event ID 68076
510(K)Number K051087  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Siemens Healthcare Diagnostics Vista Air Compressor.

Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems.

Siemens Healthcare Diagnostics Dimension Vista 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. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Code Information Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473 International: 10488224 Dimension Vista 1500 Domestic: 10444801 International: 10444802 Serial #s: 0913900306  0913900355
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Medical Device Correction letter dated April 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be Taken by the Customer 1. If an Air Compressor has already been delivered to your laboratory, or is delivered in the future for installation by your Siemens Healthcare Customer Service Engineer, please do not make any attempt to install the Air Compressor by yourself. 2. Please notify your local Siemens Healthcare Diagnostics Customer Care Center when an Air Compressor is at your site so arrangements may be made for installation by a Siemens Healthcare Diagnostics Customer Service Engineer. Please discuss the content of this letter with your Medical Director. Please complete and return the Field Correction Effectiveness Check Form attached to this letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.
Quantity in Commerce 4
Distribution Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.
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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