Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 10/21/2022
Class II
PRODUCT
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Recall Number:
Z-0119-2023
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc
VOLUME OF PRODUCT IN COMMERCE
140 US
DISTRIBUTION
Domestic distribution nationwide. Foreign distribution worldwide.
