Siemens ARTIS pheno system recalled for movement control risk
Siemens Medical Solutions USA is recalling the ARTIS pheno system, model 10849000, because it may not carry out movement control commands as intended. The system may also display the message "Limited stand/table movement, SC." The notice reports no injuries and does not specify a remedy.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Clinical staff should set the affected system aside and contact Siemens Medical Solutions USA before further use.
- Check whether the system runs software version VE50B. Model 10849000 has UDI-DI 4056869046877.
- The notice doesn't say how to get a fix; contact Siemens Medical Solutions USA for next steps.
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
- 0 in US
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, Malvern, Pennsylvania, United States
- Classification
- Class II
- Recall number
- Z-0372-2027
In the FDA's words
- Description
- ARTIS pheno. Model Number: 10849000. 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: 10849000. UDI-DI: 4056869046877. Software Version VE50B. Distribution: US Nationwide distribution in the states of CA, KY, NY, TX. Affected quantity: 0 in US
- 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.Z-0371-2027 · 1 unit
- ARTIS pheno. Model Number: 10849000. (this page)Z-0372-2027 · 0 in US