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Recall Observatory FDA recall evidence

Device 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.

Z-1497-2021

March 19, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 87620
Status
Terminated
Classification
Class II
Quantity
133 systems
Official record key
device-enforcement:Z-1497-2021

Official wording

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.

Code information: Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    issue with software