FDA Device recall Z-1814-2026
ARTIS Pheno VE30A and VE40A, Model 10849000
- FDA Device
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of ARTIS Pheno VE30A and VE40A, Model 10849000 by Siemens Medical Solutions Usa, citing 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 consta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1814-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-12 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | UDI 04056869046877 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1814-2026%22
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