| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00837-1 |
| Product Name/Description |
ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
Siemens Material Number: 10711433
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has determined that certain waste reservoirs in ADVIA Centaur XPT System were manufactured with walls that are below the nominal specification, potentially causing the following problem when the reservoir is under vacuum:
- The seam at the bottom of certain reservoirs could crack slightly and have a slight leak.
- The fitting at the bottom of the reservoir could exhibit some leaks at the interface between the reservoir and the fitting.
If a leak occurs due to a crack in the bottom of the reservoir, foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with vacuum low error # 01 600 13 24. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens are advising users to avoid any potential leak onto the floor by performing the following action during the weekly maintenance:
- Verify that no fluid has accumulated under the Waste reservoir.
- Verify that the glass jar in the bulk fluid drawer is empty and is not foaming.
Siemens will replace the defective reservoir.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |