| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00626-1 |
| Product Name/Description |
Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E
Catalogue/Lot number – 10848280, 10848355, 10848282 with SW version VD10E
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
If a position sensor fault in the swivel base axis is not detected by the system software, the C-arm system may 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. There have been no complaints from Australian customers regarding this issue.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This issue will be remedied with software update AX037 /15/S (Patch 2). Following the installation of this update, the speed of the C-arm will be limited to a pre-determined level. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |