FDA Medical devices recall ·
ARTIS Pheno VE30A and VE40A, Model 10849000 recall
- Recall number
- Z-1814-2026
- Date
- (initiated March 12, 2026)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 73
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
ARTIS Pheno VE30A and VE40A, Model 10849000
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 04056869046877
Distribution
U.S. and O.U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1814-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.