Recall Z-2182-2012— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2182-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-07-17, terminated 2014-04-03. It names one FDA 510(k) clearance: K112999. 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: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Terminated: 2014-04-03
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics·cleared 2011-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.