| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00371-1 |
| Product Name/Description |
Artis Zee, Zeego, Q, Q.zen Systems
Multiple model numbers
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 |
1/03/2022 |
| Responsible Entity |
|
| Reason/Issue |
iemens is informing that if the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the Xray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minutes later the system will block X-ray to prevent further damages and displays the message “NO XRAY: TUBE TOO HOT”. In case the problem occurs, the system cannot be operated normally.
This 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 |
Update 5/4/2024: Siemens has provided a follow up letter to customers with systems that cannot receive the initially planned correction (modification of cooling unit to add sensor + SW update) due to customer building set up. The following are actions for those systems:
- System operator is to check water level and refill water every three months.
- Siemens will apply a label on the start-up console of the Artis system in the control room to remind the user of checking cooling levels.
-Siemens will check the water level once outside the regular maintenance interval as part of this corrective action. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |