FDAFDA · Food and drugs·Recall number Z-2529-2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Published September 17, 2025 · Recall initiated: August 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Limited system movements after startup .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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