Siemens ARTIS icono biplane recalled for potential X-ray loss
Siemens Medical Solutions USA, Inc. is recalling three ARTIS icono biplane X-ray systems because they may lose X-ray functionality after system startup or restart. The affected units were distributed in CA, IA, KY, MN, NY and OH. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Contact Siemens Medical Solutions USA, Inc. about this recall and your care team about the affected system.
- Check whether the system is model 11327600 with serial number 180550, 180546 or 180569, or runs software version VE40B or VE50B.
- The notice doesn't say how to get a fix or replacement; ask Siemens Medical Solutions USA, Inc.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS icono biplane. Model Number: 11327600.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 4 products — see all of them.
Details
- Units affected
- 3 units
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, Malvern, Pennsylvania, United States
- Classification
- Class II
- Recall number
- Z-0429-2027
In the FDA's words
- Description
- ARTIS icono biplane. Model Number: 11327600. Potential for loss of X-ray functionality after system startup or restart. Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 180550, 180546, 180569. Software Versions VE40B and VE50B. Distribution: US Nationwide distribution in the states of CA, IA, KY, MN, NY, OH. Affected quantity: 3 units
- 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. (this page)Z-0429-2027 · 3 units
- ARTIS icono ceiling. Model Number: 11328100.Z-0430-2027 · 3 units
- ARTIS icono floor. Model Number: 11327700.Z-0431-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000.Z-0432-2027 · 1 unit
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ModerateFDANov 6, 2026