Device product
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Z-2529-2025
Product summary
- Event
- Event 97444
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-2529-2025
Official wording
Reason: Limited system movements after startup .
Code information: 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 pattern: US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Derived failure modes
-
Unknown
Limited system movements after startup .