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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00947-1
Product Name/Description	AXIOM Artis FA, FC, dFA, dFC, dFCM, BA, BC, dBA, dBC, dBCM, MP, dMP systems with SW version VB23N/P Catalogue/Lot number – 5904441 (FA), 7412807 (dFC), 5904466 (MP), 7555365 (dMP) with SW version VB23N/P ARTG number – 102173, 102177
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/09/2015
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	A possible position sensor fault in the swivel base axis not being detected by the system software may cause the C-arm system to move faster than normal when movement is enabled by the operator. The system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision with the patient or operator. There have been no complaints from Australian customers regarding this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	This issue will be remedied with software update AX051/15/S. Until such time users are alerted to this issue and are asked to exercise the necessary caution. This action has been closed-out on 31/08/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre