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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62611
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City Newark
State DE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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 Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial numbers 99060001 - 99062554 Class II 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. 2,554 Z-2182-2012
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