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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 Recall
Siemens Healthcare Diagnostics
see related information
Date Posted June 09, 2014
Recall Status1 Open
Recall Number Z-1733-2014
Recall Event ID 68076
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens Healthcare Diagnostics Vista Air Compressor 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
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
Siemens Healthcare Diagnostics is recalling the Vista Air Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista¿ 500 and Dimension Vista¿ 1500 systems because 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 US Distribution IL, OH and TN. One Internationally to Italy.
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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