Z-2182-2012Class II

Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R)...

Name: Z-2182-2012 Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-07-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-07-17 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully... on 2012-07-17. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2182-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Posted: 2012-08-09
Terminated: 2014-04-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an attached Field Correction Effectiveness Check Form and fax it to (302) 631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.
Quantity in commerce: 2,554
Distribution: Distributed in the US including Washington, DC, Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pacific Islands.
Product codes and lots: Serial numbers 99060001 - 99062554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2182-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2182-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code JJE

K112999Class IDimension Clinical Chemistry SystemSiemens Healthcare Diagnostics / cleared 2011-11-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)