Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

On May 20, 2022, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were informed that in the event this issue occurs, the system will switch to Bypass fluoroscopy mode. In Bypass fluoroscopy mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Customer Instructions: In the event you recognize a high squeaking scratching loud noise out of one of the system cabinets, please contact your service partner for immediate action. It is recommended to avoid performing any critical interventions on the system. Due to the possible risk of electrical shock to the technician, please ensure that your service partner (if not Siemens Healthineers) first contacts Siemens Healthineers' service organization before starting any corrective actions. The firm will replace the affected parts. The service organization will contact customers to arrange a date to perform the corrective action. To schedule an earlier appointment, contact the firm at 1-800-888-7436.