| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00212-1 |
| Product Name/Description |
Artis Zeego systems (Angiographic fluoroscopic digital diagnostic x-ray system) with software Artis VC20x/VC21A/VD10x that have a DSA license installed
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise overlay of the DSA mask image with the roadmap image displayed on the live monitor. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are being requested to keep the system (stand or table) stationary between DSA taken and DSA used as mask when executing the OGP roadmap in the DSA overlay mode. A software update will be implemented to correct the issue. |
| Contact Information |
1800 310 300 - Siemens Healthcare |