Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
Recall
- Recall Number
- Z-1598-2024
- Event Number
- 94299
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- March 21, 2024
- Posted
- April 18, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
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
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
US Nationwide distribution.
583 units