FDA recall Z-2529-2025
Siemens Medical Solutions USA, Inc · Class II · device
Product
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Reason for recall
Limited system movements after startup .
Distribution
US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-08-12
- Report date
- 2025-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Malvern, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2025