FDA DevicesClass II
ARTIS Pheno VE30A and VE40A, Model 10849000
Published: April 22, 2026Recall ID: Z-1814-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
ARTIS Pheno VE30A and VE40A, Model 10849000
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98772 |
| Address 1 | 40 Liberty Blvd |
| Address 2 | N/A |
| Code info | UDI 04056869046877 |
| Postal code | 19355-1418 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 73 |
| 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. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20260312 |
| Initial firm notification | N/A |
| Center classification date | 20260416 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. and O.U.S.