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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01126-1
Product Name/Description	Artis zee biplane and Artis Q biplane systems Catalogue Numbers: 10094141 and 10848282 ARTG Number: 273952
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	28/08/2017
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens has identified a screw connection in the ceiling mount consisting of 12 screws might not have been attached and fastened according to the quality standards for a specific number of Artis zee/Q Biplane systems. The connection is located within the rotation unit of the second plane. If such screws are not fully tightened in accordance with the specified values, single screws between the C-arm structure of the second plane and its ceiling carriage may become loose. If various screws become loosened over time, this may lead to a recognisable wobble of the C-arm, especially during fast movements. This may result in an acquired image/3D which does not allow for clinical appraisal, resulting in additional x-ray exposure for a patient. There is also the remote possibility that if, after an extended time period, all screws become loosened, parts of the second plane mechanics may become detached from the ceiling carriage of the system, and could hurt the patient and/or personnel.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens will arrange for all potentially affected systems to be examined. All affected systems will be modified so as to have the screws tightened. This action has been closed out on the 12/10/2018.
Contact Information	1800 310 300 - Siemens Customer Care Centre