ARTIS Pheno VE30A and VE40A, Model 10849000 recallZ-1814-2026 · Siemens Medical Solutions USA, Inc · initiated Mar 12, 2026
Class II Open, Classified All recalls posted in April 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
Recall details
- Recall number
- Z-1814-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 12, 2026
- Posted by the FDA
- Apr 16, 2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 73
- Product code
- OWB
- FDA submissions
- K230949, K241572
- Distribution
- U.S. and O.U.S.
Product description
ARTIS Pheno VE30A and VE40A, Model 10849000
Code information (models, lots, serial numbers)
UDI 04056869046877
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
Other devices under the same FDA submission
3 devices cleared under K230949, K241572 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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