Siemens ARTIS icono biplane system recalled for movement control risk
A recall covers 3 Siemens ARTIS icono biplane systems, model 11327600, because they may not carry out movement control commands as intended. The system may show 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
- Check whether your system is model 11327600 with software version VE50B and serial number 180361, 180569, or 180607.
- Contact Siemens Medical Solutions USA, Inc. about this recall; the notice does not list a remedy, so ask them how to get a correction.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS icono biplane. Model Number: 11327600.
- 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-0369-2027
In the FDA's words
- Description
- ARTIS icono biplane. Model Number: 11327600. 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: 11327600. UDI-DI: 4056869063317. Serial Numbers: 180361, 180569, 180607. Software Version VE50B. Distribution: US Nationwide distribution in the states of CA, KY, NY, TX. Affected quantity: 3 units
- 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. (this page)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.Z-0372-2027 · 0 in US