Official recall record
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-03-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 4056869046877
- Brand on record
- Siemens Medical Solutions USA, Inc
- Product category
- Medical Device
What the authority reported
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
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 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-02-02 · US FDA — Medical Devices
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # - 2026-03-09 · US FDA — Medical Devices
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Other recalls from this brand
- 2026-03-12 · US FDA — Medical Devices
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-09 · US FDA — Medical Devices
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system - 2026-03-09 · US FDA — Medical Devices
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 1132810
All 29 official recall notices naming Siemens Medical Solutions USA, Inc on this site →