Official recall record
ARTIS Pheno VE30A and VE40A, Model 10849000
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-03-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04056869046877
- Brand on record
- Siemens Medical Solutions USA, Inc
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2021-10-12 · US FDA — Medical Devices
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 - 2023-02-02 · US FDA — Medical Devices
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s - 2022-06-10 · US FDA — Medical Devices
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Other recalls from this brand
- 2026-03-10 · US FDA — Medical Devices
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.