Siemens ARTIS pheno X-ray system recalled for potential X-ray loss
Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno systems, model 10849000, because they may lose X-ray functionality after a system startup or restart. The recall covers serial number 164895 running software versions VE40B or VE50B, distributed in CA, IA, KY, MN, NY, and OH. The FDA classifies it as Class II and reports no injuries.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Contact Siemens Medical Solutions USA, Inc. and your care team about this system before relying on it for procedures.
- Check whether the system is model 10849000, serial number 164895, with software VE40B or VE50B (UDI-DI 4056869046877).
- The notice doesn't specify a remedy; ask Siemens Medical Solutions USA, Inc. how to get correction instructions or a fix.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS pheno. Model Number: 10849000.
- 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-0432-2027
In the FDA's words
- Description
- ARTIS pheno. Model Number: 10849000. Potential for loss of X-ray functionality after system startup or restart. Model Number: 10849000. UDI-DI: 4056869046877. Serial Number: 164895. 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.Z-0431-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000. (this page)Z-0432-2027 · 1 unit
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