Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 5/5/2021
Class II

PRODUCT

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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.

Recall Number: Z-1497-2021

REASON

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 3/19/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

133 systems

DISTRIBUTION

U.S. Nationwide and International