ARTIS Pheno VE30A/VE40A Recall - Z-1814-2026 - 73 Units

Class 2 Device Recall ARTIS Pheno

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| | Class 2 Device Recall ARTIS Pheno | |

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 | Radiation Control for Health and Safety Act |
| Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to
all affected customers dated March 9, 2026. |
| Quantity in Commerce | 73 |
| Distribution | U.S. and O.U.S. |
| Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = OWB |