21
Oct
2022

Recall- Software Issue May Lead to Hazardous Situation Requiring Use of Alternate System

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Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 10/21/2022
Class II

PRODUCT

ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

Recall Number:

Z-0119-2023

REASON

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc

VOLUME OF PRODUCT IN COMMERCE

140 US

DISTRIBUTION

Domestic distribution nationwide. Foreign distribution worldwide.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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