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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Integrated Chemistry Systems

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  Class 2 Device Recall Dimension Integrated Chemistry Systems see related information
Date Initiated by Firm November 10, 2015
Date Posted December 22, 2015
Recall Status1 Terminated 3 on August 23, 2017
Recall Number Z-0459-2016
Recall Event ID 72738
510(K)Number K130276  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Reagent Management System (RMS)
Dimension EXL with LM STM

Product Usage:
The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
Code Information Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc.
101 Silvermine Rd
Brookfield CT 06804-2047
For Additional Information Contact
203-740-6404
Manufacturer Reason
for Recall		 Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.
Quantity in Commerce 4
Distribution US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
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, INC.
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