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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension(R) Reagent Management System (RMS) Power Cord.

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  Class 2 Device Recall Dimension(R) Reagent Management System (RMS) Power Cord. see related information
Date Initiated by Firm July 17, 2012
Date Posted August 09, 2012
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-2182-2012
Recall Event ID 62611
510(K)Number K112999  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension(R) Reagent Management System (RMS) - Power Cord.

The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids.
Code Information Serial numbers 99060001 - 99062554
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact
302-631-6311
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected.
FDA Determined
Cause 2		 Device Design
Action Siemens sent an "URGENT FIELD SAFETY NOTICE" dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an attached Field Correction Effectiveness Check Form and fax it to (302) 631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.
Quantity in Commerce 2,554
Distribution Distributed in the US including Washington, DC, Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pacific Islands.
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 = SIEMENS HEALTHCARE DIAGNOSTICS
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