Siemens ARTIS icono ceiling system recalled for potential X-ray loss
Siemens Medical Solutions USA, Inc. recalled ARTIS icono ceiling systems (model 11328100) because they may lose X-ray functionality after startup or restart. The recall covers 3 units distributed nationwide, including to 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
- Do not stop using the system on your own; contact Siemens Medical Solutions USA, Inc. and your care team first.
- Check whether the affected units have serial numbers 190102, 190047 or 190124 and software versions VE40B or VE50B.
- The notice does not specify a remedy; contact Siemens Medical Solutions USA, Inc. for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
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-0430-2027
In the FDA's words
- Description
- ARTIS icono ceiling. Model Number: 11328100. Potential for loss of X-ray functionality after system startup or restart. Model Number: 11328100. UDI-DI: 4056869295923. Serial Numbers: 190102, 190047, 190124. 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.Z-0429-2027 · 3 units
- ARTIS icono ceiling. Model Number: 11328100. (this page)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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