Z-0461-2016Class II

Reagent Management System (RMS) Dimension RxL Max HM STM

Name: Z-0461-2016 Reagent Management System (RMS) Dimension RxL Max HM STM
Creator: Siemens Healthcare Diagnostics Inc.
Published: 2015-11-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-11-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc. began a recall of Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical... on 2015-11-10. FDA classified it as Class II and gives the reason as "Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0461-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2015-12-22
Terminated: 2017-08-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex reagent cartridges, allowing the Dimension system to process samples without interruption.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.
Quantity in commerce: 151
Distribution: US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
Product codes and lots: Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0461-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21
Z-0459-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21
Z-0460-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21
Z-0461-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21

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