ARTIS Pheno VE30A and VE40A, Model 10849000
FDA device recall Z-1814-2026 · posted 2026-04-16 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 73
- Distribution
- U.S. and O.U.S.
- Date initiated
- 2026-03-12
- Date posted
- 2026-04-16
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |
| ARTIS pheno (VE30A) (K230949) | Siemens Medical Solutions USA, Inc. | 2023-12-15 |