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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension EXL Chemistry System

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  Class 2 Device Recall Siemens Dimension EXL Chemistry System see related information
Date Initiated by Firm July 16, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on December 16, 2014
Recall Number Z-2553-2014
Recall Event ID 68854
510(K)Number K130276  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
Code Information All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338
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		 The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
FDA Determined
Cause 2		 Device Design
Action Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.
Quantity in Commerce 2757
Distribution Nationwide and internationally, including 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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