| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00733-1 |
| Product Name/Description |
ARTIS icono biplane
Model number: 11327600
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 |
1/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
Siemens are advising that during system tests an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
In case the issue occurs, the system will switch to “Bypass fluoroscopy” mode. In “Bypass fluoroscopy” mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available.
This issue may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that a service organisation will get in contact to organise an appointment to perform the corrective action. Customers are advised if they recognise a high squeaking scratching loud noise out of one of the system cabinets, to get in contact with Siemens for immediate action.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |