Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1615-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 2, 2015

Date Posted: May 20, 2015

Recall Number: Z-1615-2015

Event ID: 70913

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.

Status: Terminated

Product Quantity: 17801

Code Information:

Model numbers: D045912, D193440, D140066; Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838

Distribution Pattern:

Distributed in the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated