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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00229-1
Product Name/Description	AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system) Catalogue Numbers: 7555365, 10094141, 10094139, 10094137, 10094135, 10280959, 10848281, 10848280, 10848282, 7413078, 7412807, 7008605, 10848355, 7728392, 7555357, 7727717 ARTG Numbers: 102173 and 102177
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/03/2016
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Due to a leak in the cooling system, fluids could seep into the equipment cabinet. This leak can occur sporadically in the affected systems. The issue was identified during regular field observations. In this case, there was a leak in the hose connectors. Loss of coolant can result in cooling system failure, and in a worst case scenario, this leak can cause system failure.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens are advising users that service personnel will be replacing the affected couplings in order to prevent the issue from occurring. This action has been closed out on 26/09/2018
Contact Information	1800 310 300 - Siemens Technical Support Centre