The FDA announced on March 21, 2024, that Siemens Medical Solutions USA, Inc. is recalling 583 units of Artis interventional fluoroscopic X-ray systems due to a coolant level hazard. The agency issued recall number Z-1598-2024 for the voluntary Class II action.
How to tell if you have it
- Siemens Artis zee floor (Model/UDI-DI: 4056869010045)
- Siemens Artis zee ceiling (Model/UDI-DI: 4056869010052)
- Siemens Artis zee multi-purpose (Model/UDI-DI: 4056869010076)
- Siemens Artis zee biplane (Model/UDI-DI: 4056869010069)
- Siemens Artis zeego (Model/UDI-DI: 4056869010083)
- Siemens Artis Q floor (Model/UDI-DI: 4056869009971)
- Siemens Artis Q ceiling (Model/UDI-DI: 4056869009988)
- Siemens Artis Q biplane (Model/UDI-DI: 4056869009995)
- Siemens Artis Q zeego (Model/UDI-DI: 4056869010007)
- Siemens Artis Q.zen floor (Model/UDI-DI: 4056869010014)
- Siemens Artis Q.zen ceiling (Model/UDI-DI: 4056869010021)
- Siemens Artis Q.zen biplane (Model/UDI-DI: 4056869010038)
- Siemens Artis zee floor MN (Model/UDI-DI: 4056869010090)
- Siemens Artis zee biplane MN (Model/UDI-DI: 4056869010106)
The hazard
According to the FDA, the coolant level in the cooling circuit may drop below a certain level, resulting in insufficient X-ray tube cooling. The system will display the message "TUBE HOT, have a break" and cannot be operated normally, which may necessitate canceling clinical treatment or continuing on an alternative system.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall dated June 8, 2026, and the Siemens ARTIS icono ceiling recall dated May 20, 2026. Other recent recalls of similar products include the Philips Integris-Allura System Recall (April 28, 2026), the Philips Azurion System Recall (April 28, 2026), and the Philips Allura Xper FD20/10 recall (December 15, 2025).