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.
FDA Recall Z-1615-2015 · Posted 2015-05-14
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-04-02
Date Terminated2016-08-17
Product Quantity17801
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in the country of Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc. · 2013-03-22K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics · 2011-11-22K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MODDade Behring, Inc. · 2008-03-13
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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