Recall Z-2748-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: 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 Artis family include cardiac angiography, neuro angiography, general angiograph
| Date | Jun 22, 2018 |
| Status | Terminated |
| Reason | Potential hardware issue which may cause thermal effects and possible damage to system parts. |
| Root cause | Nonconforming Material/Component |
| Action | On June 22, 2018, Siemens Healthineers issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. In the event the problem occurs, the system can be operated normally, however, in the case of a leakage current, X-ray will not be possible. This may result in a situation where it is necessary to cancel or restart clinical treatment or to continue treatment on an alternative system. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has be |
| Quantity | 605 units in total |
| 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 |