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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 April 02, 2015
Date Posted May 14, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1615-2015
Recall Event ID 70913
510(K)Number K073604  K130276  K112999  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM.

The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Code Information Model numbers: D045912, D193440, D140066;  Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838
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		 Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens sent an Urgent Field Safety Notice, dated April 2015, was issued for distribution to affected customers in Japan to notify them of the issue. A Siemens Service Representative will visit customer sites to inspect the Dimension instrument power plug and wall outlet configuration. If the instrument is configured with a non-standard 15 Amp plug/outlet or a 20 Amp twist lock plug, Siemens will correct the issue identified, ensuring that the system is installed according to the instrument requirements.
Quantity in Commerce 17801
Distribution Distributed in the country of Japan.
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.
510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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