Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00449-1
Product Name/Description	ARTIS zee/Q systems with Large Display Catalogue Numbers: 10094137, 10094135, 10280959, 10848281, 10848283, 10094141 WAND Number: 160415-WAND-6LT3VY ARTG Number: 273952 Siemens Healthcare - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/05/2018
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	It has been identified by Siemens that the Large Display does not show an image due to a technical problem. This might occur after the Large Display returns from power save mode. The Large Display stays black without showing an error message. X-ray is still possible. The problem occurs sporadically and only when the display is returning from power save mode. It does not occur during an ongoing procedure.
Recall Action	Product Defect Correction
Recall Action Instructions	Siemens is advising they will contact impacted customers to arrange a firmware update to correct this issue. This action has been closed out on 06/02/2019
Contact Information	1800 310 300 - Siemens Customer Care Centre