Recall – Potential issue with x-ray system software update

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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