Recall Z-1340-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography,
| Date | Jan 24, 2020 |
| Status | Terminated |
| Reason | Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements |
| Root cause | Device Design |
| Action | Siemens issued Urgent Medical Device Correction letter dated January 24, 2020 A via AX064/19/S ( corrective action via AX063/19/S), stating reason for recall, health risk and a corrective action: In the event the robotic stand shows stuttering movements or a squealing noise while initiating movements, do not move the robotic stand and C-arm any longer. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing the |
| Quantity | 96 US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |