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Siemens Healthcare Diagnostics, Inc. recalls Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dime
Recalled May 20, 2015 · FDA recall Z-1615-2015 · Siemens Healthcare Diagnostics
Hazard
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 Class II
Units
17801
Sold at
Distributed in the country of Japan.
Description
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.
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →