Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
What this means
Siemens has recalled certain ARTIS Pheno VE30A and VE40A imaging systems used in hospitals and medical facilities. During 3D imaging procedures, these systems may produce images with uneven brightness, potentially leading to less accurate reconstructions and unintended low-dose radiation exposure to patients.
- If your facility uses an ARTIS Pheno VE30A or VE40A system (Model 10849000), contact Siemens Medical Solutions USA immediately for guidance
- Do not perform 3D acquisitions until you receive instructions from Siemens
- Check the UDI on your system: 04056869046877
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2026More Siemens recalls
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