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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Pheno

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 Class 2 Device Recall ARTIS Phenosee related information
Date Initiated by FirmMarch 12, 2026
Date PostedApril 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1814-2026
Recall Event ID 98772
510(K)NumberK230949 K241572 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS Pheno VE30A and VE40A, Model 10849000
Code Information UDI 04056869046877
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSiemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
Quantity in Commerce73
DistributionU.S. and O.U.S.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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