Z-1615-2015Class II

Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL...

Name: Z-1615-2015 Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-04-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-04-02 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM... on 2015-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1615-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-02
Posted: 2015-05-14
Terminated: 2016-08-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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 root cause: 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.
Product codes and lots: Model numbers: D045912, D193440, D140066; Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1615-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-14

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)