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 angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

Potential hardware issue which may cause thermal effects and possible damage to system parts.

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 been completed. Siemens will correct the error by updating all affected generators with a RCD (Residual Current Device) to detect leakage currents via Update Instruction AX060/16/S. Additionally, Siemens recommends installing a RCD (Residual Current Device) in the electrical system of the hospital as an appropriate backup system and general electrical protection. You may continue to use the Artis Q and Artis Pheno systems while awaiting implementation of the corrective action. Siemens Healthineers will contact customers to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.