Recall Z-1814-2026
Siemens Medical Solutions USA, Inc · initiated March 12, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARTIS Pheno VE30A and VE40A, Model 10849000
Codes / lots: UDI 04056869046877
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
Details
- Recall number
- Z-1814-2026
- Initiated
- March 12, 2026
- Posted by FDA
- April 16, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 73
- Distribution
- U.S. and O.U.S.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA