Data Foundry

Medical device recalls 2012

Dimension — Class II medical device recall Z-2182-2012

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2012-08-15, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent

Recall numberZ-2182-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Healthcare Diagnostics, Inc., Newark, DE, United States
Recall initiated2012-07-17
Classified2012-08-09
Reported by FDA2012-08-15
Terminated2014-04-03
DistributedAK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Quantity2,554
Reason classesdevice malfunction
Serial numbers99060001, 99062554

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2182-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.