| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00054-1 |
| Product Name/Description |
Artis One in conjunction with table
Catalogue Number: 10848600
ARTG Number: 222194 (Siemens Healthcare Pty Ltd- Artis one - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has been made aware of an issue with the Artis one systems in conjunction with Artis tables. The Artis table top carriage is mounted on top of the table base and fixed with a bolt. A fixation ring is used to secure the bolt.
In the event of a missing or wrongly installed fixation ring, the bolt will remain in place and the patient table may appear to operate normally. In extreme cases after long periods of use, the bolt persistently bears the unexpected force from non-vertical direction and may slide out of its base and lead to the table top carriage slide to the floor.
No complaints have been received for the Artis one system to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens will be in contact with affected users to arrange for a service technician to examine potentially affected tables. The positioning of the bolt as well as the fixation rings will be verified and if necessary corrected or replaced.
This action has been closed out on 11/09/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |