ARTIS Pheno VE30A and VE40A, Model 10849000
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 12, 2026 |
| Reported | April 22, 2026 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Country / region | United States PA |
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.
Affected products
- ARTIS Pheno VE30A and VE40A, Model 10849000
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