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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Number | Z-1598-2024 |
| Risk Class | Class 2 |
| Recall Qty | 582 |
| Classification Date | 2024-04-18 |
| Recall Link | Recall Link |
| Notes/Alerts | N/A |
| Recall Reason | 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. |
DEVICE
| Manufacturer | Siemens Medical Solutions USA, Inc |
|---|---|
| Model Name | Various Artis Models (14) |
| Model Number | Various Models (14) |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Interventional fluoroscopic x-ray system. |
| Serial Number(s) | Various SNs (583) |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
1. 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:
2. 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.
3. 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.
4. 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.
5. 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.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Siemens. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
