FDAHealthAugust 12, 2025

Siemens Medical Solutions USA, Inc — Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

⚠️ Limited system movements after startup .

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: August 12, 2025

US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.

What's affected?

Product: Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Brand: Siemens Medical Solutions USA, Inc
Lot code: Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097,

Additional details

Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097,

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.

View original FDA notice →

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