Recall – Potential issue with x-ray system software update

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


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


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.


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


133 systems


U.S. Nationwide and International

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

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