Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-01303-1 |
Product Name/Description |
Artis Zeego Systems (Fluoroscopic angiographic x-ray system)
C-arm Serial Number Range: 1000 to 1599
ARTG Number: 102177 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/12/2014 |
Responsible Entity |
|
Reason/Issue |
A cable inside the c-arm of systems affected may have been routed in an inappropriate manner and there is a potential that with increased wear a cable inside the c-arm may break. A cable break will result in restricted functionality and even system failure. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Siemens is replacing the affected cable harness with a modified version in addition to re-routing the cables to prevent wear. This action has been closed-out on 01/03/2016. |
Contact Information |
1800 310 300 - Siemens Technical Support Centre |