ARTIS Pheno VE30A and VE40A recall
ARTIS Pheno VE30A and VE40A, Model 10849000
Why was ARTIS Pheno VE30A and VE40A recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 04056869046877
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 73
- Distribution
- U.S. and O.U.S.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)