FDA Enforcement
Class II
Ongoing
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Recall: Z-2529-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2529-2025
- Event ID
- 97444
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- August 12, 2025
- Classification Date
- September 5, 2025
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
Description
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Reason
Limited system movements after startup .
Code Info
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,
Distribution
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Quantity
20 units