| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00483-1 |
| Product Name/Description |
Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B
(fluoroscopic angiographic x-ray system)
Catalogue numbers: 10094135, 10094141, 10094139
ARTG Number - 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
A possible position sensor fault in the swivel base axis not being detected by the system software may cause the C-arm system to move faster than normal when movement is enabled by the operator. The system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This issue will be remedied with software update (Patch 12). Following the
installation of this update, the possible speed of the Artis system will be limited to the
permissible level. This action has been closed-out on 19/08/2016. |
| Contact Information |
1800 310 300 Siemens Technical Support Centre |