FDA-Device2025-09-17Class II

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Siemens Medical Solutions USA, Inc
Hazard

Limited system movements after startup .

Sold states
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Affected count
20 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2025

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