| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01558-1 |
| Product Name/Description |
ARTIS icono / pheno system in combination with a Siemens Healthineers VE OR Table
Model number: 4056869046877, 4056869063317 & 4056869149325
ARTG 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 |
20/12/2022 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare has identified a potential issue with the ARTIS icono / pheno system in combination with a Siemens Healthineers VE OR Table. During transversal table movement, the rolling bearing, which is part of the linear guide rail and enables the transversal table movement, may get dislocated. The rolling bearing may fall out of the linear guide rail and the mechanical connection between table top and table base may get lost.
As a result, the patient may fall off the table and the patient and/or the user may be injured. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Update Dec 2023: Siemens will contact customers to schedule an appointment to perform the corrective action. Customers can contact Siemens for an earlier appointment if required.
The completion of corrective action is expected by end of Dec 2024.
Siemens has also released an addendum to the user manual:
Please perform a visual inspection of the tabletop bearings on each side of the patient table (four locations) on a daily basis according to Artis Addendum instructions. |
| Contact Information |
1800 310 300 - Customer care - Siemens |