ARTIS Pheno VE30A and VE40A recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIOngoing
Summary: Siemens Medical Solutions USA, Inc is recalling 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.
What is being recalled
ARTIS Pheno VE30A and VE40A, Model 10849000
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. and O.U.S.
How to tell if yours is affected
UDI 04056869046877
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1814-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 12, 2026 |
| Reported | April 22, 2026 |
| Company | Siemens Medical Solutions USA, Inc |
| Company location | Malvern, PA, United States |
| Initiated by | FDA Mandated |
| Quantity | 73 |
More recalls from Siemens Medical Solutions USA, Inc · all medical device recalls · recalls from March 2026