| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00945-1 |
| Product Name/Description |
AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D
Catalogue/Lot Number – 7555373 (dFA), 7412807 (dFC), 7727717 (dFCM) 7555357 (dBA) 7728392 (dBC) 7555365 (dMP) with SW version VB35D
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
A possible position sensor fault in the swivel base axis is not being detected by the system software and this may cause the C-arm 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 with a patient or operator.
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 AX047/15/S. Until such time users are alerted to this issue and are asked to exercise the necessary caution. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |