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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00836-1
Product Name/Description ARTIS Q, ARTIS pheno systems and X-ray generator

Catalogue Numbers: 10848282, 10848281, 10848280, 10848283, 10848355, 10849000

ARTG Number: 273952
(Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/06/2018
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens have identified that in the event of a short-circuit within the X-ray tube, a current leakage may cause an overload of the X-ray generator. If this current leak remains undetected it may cause damage to the generator by overheating after-which, taking an X-ray will not be possible.
Recall Action Product Defect Correction
Recall Action Instructions Siemens are advising they will contact customers to schedule the installation of a Residual Current Device (RCD) on affected generators in order to detect current leakages.

This action has been closed out on 31/05/2019
Contact Information 1800 310 300 - Siemens Customer Care Centre