| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01163-1 |
| Product Name/Description |
Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)
Catalogue Number: 10094137
Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518
All systems equipped with a ceiling stand with serial numbers from 10701 to 11557
ARTG Number: 120177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Cables in the cable harness of the ceiling carriage may have received wear and tear or damage resulting in loss of system movement or loss of complete functionality. Siemens technical specialists have advised that this issue could result in a limited or total loss of functionality with regards to the system movement. The cable damage caused by this issue would only affect system movement, not the imaging. However, as this type of system may be used during procedures for the placement of catheters, pacemakers, transcatheter aortic valve implantations etc. The loss of system movement may limit the available imaging during this type of procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is inspecting all potentially affected cables and installing an additional cable guide system to prevent wear if necessary. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |