Siemens Medical Solutions Usa, Inc: Interventional Fluoroscopic X-ray System
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Reason
- During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-12
- Status
- Open, Classified
- Distribution
- U.S. and O.U.S.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/33fecc20-f469-47c6-8745-711ce50ae980