| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00550-1 |
| Product Name/Description |
Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly
Catalogue/Lot numbers: X-ray tube assemblies 10144184 and 10145086 from a specific production lot
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Due to a production fault in a specific production lot of the triple-focus X-ray tube assembly, there is a possibility that the "small focus" may fail. If this occurs, no further radiation release will be possible from this focus source. The "large focus" and "micro focus" will still be operational. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 310 300 Siemens Technical Support Centre |