| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01307-1 |
| Product Name/Description |
Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system))
Serial Numbers: 109000 to 109091 (Artis Q), and 111000 to 111005 (Artis Q.zen)
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
During regular product monitoring, wear on system cabling was identified. In particular, wear may occur at the cable outlet of the inner C-arm. This problem is not systematic, but occurs sporadically on individual systems throughout the lifetime of the system. Suboptimal routing of the cable may result in increasing wear. Without intervention to manage this wear, damage to cabling may result in limited functionality and, in the worst case, system failure where a procedure may need to be terminated.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The existing cable routing at the C-arm will be modified to prevent cable damage. The following
hardware modification will be implemented in the field :
1. A modified cable outlet to provide additional space for the cabling.
2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area
most at risk of wear
All systems will be checked to determine if there is existing damage to cabling. Where damage
is observed, the entire cable harness will be replaced. This action has been closed-out on 14/07/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |