Official recall record
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee m
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-03-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 4056869010045
- Brand on record
- Siemens Medical Solutions USA, Inc
- Product category
- Medical Device
What the authority reported
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may 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 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2022-12-16 · US FDA — Medical Devices
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee b
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