Agency classClass IIOur severity:High FDA (Devices)·Z-0558-2019·Announced 2018-12-12

Siemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak

Siemens is recalling 64 Artis Zee and Zeego angiography systems due to a possible cooling hose leak that can cause the X-ray tube to overheat and block imaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the defect can interrupt clinical treatment, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 64 units of the AXIOM Artis zee and Zeego angiography systems (model no. 10272462). These systems are used for diagnostic imaging and interventional procedures. The recall is due to a possible leakage in a hose within the cooling unit of the X-ray tube.

The leak can cause the system to lose coolant, preventing the X-ray tube from cooling sufficiently. This results in the system displaying a "Tube hot, have a break" message, followed by a "NO XRAY, TUBE TOO HOT" message that blocks X-ray usage. The issue is sporadic and may occur during ongoing clinical procedures, potentially delaying planned procedures or requiring the termination and transfer of emergent clinical treatments.

Sixteen of the affected units are in the United States, distributed to Arkansas, California, Kansas, Kentucky, Maryland, Minnesota, New Mexico, Oklahoma, Pennsylvania, Rhode Island, Texas, and Utah. Specific serial numbers are listed in the official recall notice. Healthcare facilities should contact Siemens for instructions on how to address the issue.

The recalled product

Product: Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography Systems
Hazard: overheating
equipment-failure

Distribution

Distributed in 12 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · overheating