Official recall record
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 1
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 4056869149325
- Brand on record
- Siemens Medical Solutions USA, Inc
- Product category
- Medical Device
What the authority reported
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
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.
- 2023-06-19 · US FDA — Medical Devices
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate - 2025-05-15 · US FDA — Medical Devices
interventional fluoroscopic x-ray system
Other recalls from this brand
- 2026-03-12 · US FDA — Medical Devices
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-10 · US FDA — Medical Devices
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. - 2026-03-09 · US FDA — Medical Devices
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
All 29 official recall notices naming Siemens Medical Solutions USA, Inc on this site →