Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 10/21/2022
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Siemens Medical Solutions USA, Inc
VOLUME OF PRODUCT IN COMMERCE
Domestic distribution nationwide. Foreign distribution worldwide.