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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00782-1
Product Name/Description Artis Q and Artis Q zen systems (Fluoroscopic X-ray systems)

Multiple material numbers with software VD10D and Large Display

ARTG Number: 102177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/07/2014
Responsible Entity Siemens Ltd
Reason/Issue Siemens has I identified the following issues with the Artis Q and Artis Q zen systems:
1. In certain circumstances the release of radiation is blocked in connection with an error with the Large Display, for example, where an image cannot be displayed on the Large Display. In rare cases the system misinterprets the status of the Large Display and blocks the release of radiation.

2. In the case of installations configured with a hospital emergency power supply for the entire system, radiation release may be blocked due to a software error, because a non-existent emergency power situation is detected by mistake.

3. The coupling of failures caused by an electronic control element might lead to a radiation abort.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing a software patch to correct this issue. The software limits the blockage of radiation release to three seconds and the screen in the control room displays the message "No Xray, try again". After the next attempt, radiation can then be released without restriction. The software modification also prevents misinterpretation of the emergency power supply issue. An additional hardware signal supression component will be fitted to mitigate electronic control element failure. This action has been closed-out on 01/03/2016.
Contact Information 1800 310 300 - Siemens Technical Support Centre