FDA recall, , Moderate risk
Siemens Artis Pheno Angiography Systems
ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc. of Malvern, Pennsylvania, recalled its ARTIS Pheno VE30A and VE40A, Model 10849000, beginning March 12, 2026, according to the FDA. During 3D acquisitions, lighter and darker patient images may be captured, resulting 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, which may result in unintentional low-dose radiation exposure to a patient. The FDA added the recall to its Enforcement Report on April 16, 2026, and it was distributed in the U.S. and O.U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ARTIS Pheno VE30A and VE40A
- Model number
- 10849000
- UDI-DI
- 04056869046877
Recall details
- Company began the recall
- Sold in
U.S. and O.U.S.
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98772
- Recall number
- Z-1814-2026
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
