Siemens ARTIS icono floor system recalled for movement control risk
Siemens Medical Solutions USA is recalling one ARTIS icono floor system (model 11327700). The system may not execute movement control commands as intended and may display the message "Limited stand/table movement, SC." No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Set aside the affected unit and contact Siemens Medical Solutions USA before using it further.
- Identify the unit by model 11327700, serial number 170601, UDI-DI 4056869149325 and software version VE50B.
- The notice doesn't specify a remedy; ask Siemens Medical Solutions USA 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 (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-0371-2027
In the FDA's words
- Description
- ARTIS icono floor. Model Number: 11327700. 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: 11327700. UDI-DI: 4056869149325. Serial Number: 170601. 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.Z-0370-2027 · 1 unit
- ARTIS icono floor. Model Number: 11327700. (this page)Z-0371-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000.Z-0372-2027 · 0 in US