Recall Z-1814-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Pheno VE30A and VE40A, Model 10849000
| Date | Apr 16, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026. |
| Quantity | 73 |
| Distribution | U.S. and O.U.S. |
| FDA record | Open on fda.gov |