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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01251-1
Product Name/Description	All Magnetom MRI systems with superconductive magnets Various System Names Catalogue Numbers: 10433372, 10432914, 7391167, 10849579, 10018165, 10352127, 10836666, 10836618, 10849582, 10849583, 10432915, 10849580, 7104719, 10655588, 7104594, 106557, 10018223, 7387074, 10018221 and 10276755 ARTG Numbers: 98319, 144221, 98485, 154128 and 188470
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/12/2015
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	In some cases the quench lines of some superconducting magnets may not have been properly installed. Quench lines are installed to vent helium gas in the event of a quench (i.e., sudden loss of superconductivity when the temperature is raised). In the unlikely event that a quench were to occur, a damaged/inappropriately installed quench line could lead to a displacement of oxygen, cold burns and/or could pose a risk to users, patients or others if the helium gas is vented to a closed area inside a building.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor is advising users to contact their contract quench line installer (Siemens or third party) to perform a quench line inspection. In the interim, users are reminded that it is important to follow the guidelines outlined in the System Owner Manual, including ensuring that they have an emergency plan in place in the event helium gas escapes into the magnet room or other rooms. This action has been closed-out on 04/05/2017.
Contact Information	1800 310 300 - Siemens Technical Support Centre