Recall

Class II — Siemens Medical Solutions USA, Inc

Recalling firm	SIEMENS MEDICAL SOLUTIONS USA, INC.
Registered facility	View this company's 9 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Terminated
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.
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.
Quantity	133 systems
Distribution	Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
Initiated	2021-03-19
Classified	2021-04-26
Terminated	2021-11-09
Recall number	Z-1497-2021
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-1497-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87620/

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