Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A

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.

Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.

• FDA enforcement recordOfficial FDA database entry for Z-1814-2026
• FDA 510(k) clearance · K230949The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241572The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Medical Solutions USA, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.