Recall Z-1598-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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 Ar
| Date | Apr 18, 2024 (initiated Mar 21, 2024) |
| Status | Open, Classified |
| 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 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 |
| Root cause | Device Design |
| Action | 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 sys |
| Quantity | 583 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |