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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01114-1
Product Name/Description Dimension Integrated Chemistry Systems.

Dimension EXL with LM
Dimension Reagent Management System (RMS)
Dimension RxL Max HM

Catalogue Numbers: 10472176, 10444833 and 10444829

ARTG Number: 174699

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/11/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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. The absence of the safety cover results in a potential electrical hazard to the operator. This issue does not impact patient results.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing a safety warning to be placed on the machine as an interim measure. A service engineer will be inspecting all units and installing a cover where required.

This action has been closed out on 25/10/2018
Contact Information 1800 310 300 - Technical Support Centre