Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00813-1
Product Name/Description Artis Systems in conjunction with Artis Table

Catalogue Numbers: 5904441, 7728392, 7412807, 7413078, 7008605, 7555357, 7555373, 7727717, 10094141, 10094135, 10094137, 10280959, 10848281, 10848280, 10848283, 10848282 with Artis table

ARTG Numbers: 273952, 222194 and 274081
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/06/2017
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has identified an issue where large amounts of liquid can enter the Artis table which may result in electric table movement failure. The patient table will not be able to be moved, or will only have limited movements. If function failure occurs, it could result in a situation where it may be necessary to cancel treatment or restart clinical treatment on a functioning system.
Recall Action Recall for Product Correction
Recall Action Instructions Various gaps and openings on the top of the table will recieve additional sealing.

This action has been closed out on the 16/11/2018.
Contact Information 1800 310 300 Siemens Customer Care Centre