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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01004-1
Product Name/Description	AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system) Catalogue/Lot Numbers: 5904433, 5904649, 5904466, 5904441, 5904656, 7728350, 7007755, 7412807, 7727717, 7728392, 7413078, 5917054, 7555373, 7555357, 7008605, 7555365, 10502501, 10848280, 10848353, 10502502, 10848281, 10848354, 10502505, 10848283, 10502504, 10848282, 10848355, 10502507, 10094135, 10094142, 10094137, 10094143, 10094141, 10094139, 10280959 ARTG Numbers: 102173, 27395, 102177
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/07/2016
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens has identified that contaminants in the form of biomass can develop in the cooling system of Artis systems, which can result in damage to the pump system. The presence of contaminants in the tube cooling circuit could impair the performance of the pump. The tube assembly can become overheated so that no radiation can be released. There is a risk that an ongoing procedure cannot be continued, however, the probability of this occurring is unlikely.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising users that a technician will be installing an additional external filter in the cooling water circuit to prevent the failure of the pump system. A further correction will be implemented to prevent the development of biomass in the cooling circuit as a permanent correction. Siemens is advising that there is no requirement to re-examine patients. This action has been closed-out on 27/03/2018.
Contact Information	1800 310 300 - Siemens Customer Care Centre