Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00775-1 |
Product Name/Description |
Artis zee and Artis zeego systems
Multiple material numbers with software VC21B and Large Display
ARTG Number: 102177 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
11/07/2014 |
Responsible Entity |
|
Reason/Issue |
Under certain circumstances the release of radiation can become blocked unnecessarily. The system to block the release of radiation after the system has booted up if an error occurs with the Large Display. The radiation block remains even if the error that triggered the block was a temporary one or has been cleared. |
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. This action has been closed-out on 02/06/2016. |
Contact Information |
1800 310 300 - Siemens Technical Support Centre |