| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00471-1 |
| Product Name/Description |
ARTIS pheno systems
Catalogue Number: 10849000
ARTG Number: 273952
(Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified an issue with ARTIS pheno systems. If the C-arm is moved manually longitudinal to a fully extended position it may occur rarely, that the system's safety stop mechanism may be activated. As a result, the C-arm of ARTIS pheno stops the movement and can drop up to 20 mm (0.8"). This can happen during an ongoing procedure.
If this issue occurs, the system performs a safety stop. All C-arm movements are blocked and can only be reactivated by a field service engineer. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens are currently working on a solution to eliminate the root cause of the problem.
In the interim, users are advised to avoid driving the C-arm into a fully extended longitudinal position. A fully extended longitudinal position is reached when the stand arms are almost completely stretched out.
This action has been closed out on 27/02/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |