Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
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.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 73
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, N/A, Malvern, PA, United States
- Classification
- Class II
- Recall number
- Z-1814-2026
In the FDA's words
- Description
- ARTIS Pheno VE30A and VE40A, Model 10849000 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. UDI 04056869046877 Distribution: U.S. and O.U.S. Affected quantity: 73
- 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.
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