Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 100
FDA device recall Z-1598-2024 · posted 2024-04-18 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
- Action taken
- Siemens issued Urgent Medical Device Correction letter (AX034/23/S) to US accounts Director of Diagnostic Imaging and/ or Radiology Laboratory to users of Artis zee, Artis zeego, Artis Q, Artis Q.zen and Artis Q zeego systems on 3/21/24. Letter states reason for recall, health risk and action to take: As the released corrective action to install a water level sensor is not applicable to your site due to the local building setup, Siemens Healthineers is advising users of Artis systems to check the cooling units and refill with water according to the provided Instruction for Use of the Artis system. As described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water In addition, a label will be affixed on the start-up console of the Artis system in the control room to remind users to check the cooling water levels. As a courtesy, Siemens service organization will check the water level once outside the regular maintenance interval. Prospectively, the check of the cooling level is part of each maintenance. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. Acknowledge Receipt of this Safety Advisory Notice
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 583 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-03-21
- Date posted
- 2024-04-18
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Artis zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |