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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01240-1
Product Name/Description	Artis systems with wireless footswitch Products Affected: AXIOM Artis FC, AXIOM Artis MP, AXIOM Artis dTA, AXIOM Artis dFC, AXIOM Artis dTC, AXIOM Artis dBA, AXIOM Artis dMP, AXIOM Artis dFC Magnetic Navigation, AXIOM Artis dBC, Artis zee floor, Artis zee ceiling, Artis zee multi-purpose, Artis zee biplane, Artis zeego, Artis Q floor, Artis Q ceiling, Artis Q biplane, Artis zeego.Q, Artis Q.zen floor, Artis Q.zen biplane, Artis one, ARTIS pheno ARTG Numbers: 273952 and 222194
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/09/2017
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens is advising that the wireless foot switch can fail due to impacts by external factors, such as electrostatic discharge that exceeds a certain intensity. If a wireless foot switch fails, it will no longer be possible to use it to release radiation, however it will still be possible to trigger exposures if a wired foot switch or hand switch is present. Fluoroscopy with the hand switch is not possible. This may result in a situation where it is necessary to cancel or restart clinical treatment or transfer the treatment to a functioning system.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising users that the affected control assembly will be replaced with a new version to correct the issue. This action has been closed out on 06/02/2019
Contact Information	1800 310 300 - Siemens Customer Care Centre