FDA Enforcement Class II Terminated

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.

Recall: Z-2182-2012 · Reported August 15, 2012

Enforcement

Recall Number
Z-2182-2012
Event ID
62611
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Siemens Healthcare Diagnostics, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 15, 2012
Initiation Date
July 17, 2012
Classification Date
August 9, 2012
Termination Date
April 3, 2014
Address
500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

Description

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

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.

Code Info

Serial numbers 99060001 - 99062554

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.

Quantity

2,554