Siemens ARTIS icono floor system recalled for potential X-ray loss
Siemens Medical Solutions USA, Inc. is recalling one ARTIS icono floor X-ray system because it may lose X-ray functionality after startup or restart. No injuries have been reported. The system was distributed in CA, IA, KY, MN, NY, and OH.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Contact Siemens Medical Solutions USA, Inc. and your care team before stopping use of this system, since losing X-ray function could affect patient care.
- Check that the model number is 11327700, the serial number is 170611, and the software version is VE40B or VE50B.
- The notice doesn't say how to get a repair or update; contact Siemens Medical Solutions USA, Inc. for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS icono floor. Model Number: 11327700.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 1 unit
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, Malvern, Pennsylvania, United States
- Classification
- Class II
- Recall number
- Z-0431-2027
In the FDA's words
- Description
- ARTIS icono floor. Model Number: 11327700. Potential for loss of X-ray functionality after system startup or restart. Model Number: 11327700. UDI-DI: 4056869149325. Serial Number: 170611. Software Versions VE40B and VE50B. Distribution: US Nationwide distribution in the states of CA, IA, KY, MN, NY, OH. Affected quantity: 1 unit
- Hazard
- Potential for loss of X-ray functionality after system startup or restart.
4 products in this recall
Siemens ARTIS X-ray systems recalled for potential function loss
Siemens is recalling four ARTIS X-ray imaging systems, eight units in total, because they may lose X-ray functionality after the system starts up or restarts. The products are the ARTIS icono biplane, ARTIS icono ceiling, ARTIS icono floor, and ARTIS pheno, distributed in CA, IA, KY, MN, NY, and OH. The notice reports no injuries.
The agency lists each product separately. Check every one you might have.
- ARTIS icono biplane. Model Number: 11327600.Z-0429-2027 · 3 units
- ARTIS icono ceiling. Model Number: 11328100.Z-0430-2027 · 3 units
- ARTIS icono floor. Model Number: 11327700. (this page)Z-0431-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000.Z-0432-2027 · 1 unit
More from Siemens
See all- Siemens ARTIS icono biplane system recalled for movement control risk
ModerateFDANov 6, 2026