Recall Z-0461-2016— Siemens Healthcare Diagnostics Inc.

Name: FDA recall Z-0461-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-10

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc., initiated 2015-11-10, terminated 2017-08-23. It names one FDA 510(k) clearance: K112999. 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Terminated: 2017-08-23
Firm location: Brookfield, CT, 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

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.

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.

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