Siemens ARTIS icono ceiling system recalled for movement control risk
Siemens Medical Solutions USA, Inc. is recalling one ARTIS icono ceiling system because it may not carry out movement control commands as intended. The system may also show the message "Limited stand/table movement, SC." The notice reports no injuries, and the unit was distributed in CA, KY, NY and TX.
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 unit before continuing to rely on it for movement control, since the notice gives no remedy.
- Check that the unit matches Model 11328100, UDI-DI 4056869295923, serial number 190047, and software version VE50B.
- The notice doesn't say how to get a correction or replacement; ask Siemens Medical Solutions USA, Inc. for the 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 (under 100 years)
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-0370-2027
In the FDA's words
- Description
- ARTIS icono ceiling. Model Number: 11328100. Potential that the system may not execute movement control commands as intended and may display the following message to the user, "Limited stand/table movement, SC." Model Number: 11328100. UDI-DI: 4056869295923. Serial Number: 190047. Software Version VE50B. Distribution: US Nationwide distribution in the states of CA, KY, NY, TX. Affected quantity: 1 unit
- Hazard
- Potential that the system may not execute movement control commands as intended and may display the following message to the user, "Limited stand/table movement, SC."
4 products in this recall
Siemens ARTIS imaging systems recalled for possible movement control failure
Four Siemens ARTIS imaging systems are in this recall: ARTIS icono biplane, ARTIS icono ceiling, ARTIS icono floor and ARTIS pheno. The systems may not carry out movement control commands as intended, and may show the message "Limited stand/table movement, SC." The affected units are in California, Kentucky, New York and Texas, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- ARTIS icono biplane. Model Number: 11327600.Z-0369-2027 · 3 units
- ARTIS icono ceiling. Model Number: 11328100. (this page)Z-0370-2027 · 1 unit
- ARTIS icono floor. Model Number: 11327700.Z-0371-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000.Z-0372-2027 · 0 in US