FDA-Device2026-07-08Class IIPROCESSING DEFECT
Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
What this means
The Siemens ARTIS icono floor medical imaging system may lose movement capability when the detector lift height is adjusted to its maximum or minimum position. This affects 30 units with specific serial numbers distributed nationwide.
- If you operate this device, contact Siemens Medical Solutions USA immediately for repair or instructions.
- Do not adjust the detector lift height to maximum or minimum limits until the issue is resolved.
- Check your device serial number against the recall list to confirm if your unit is affected.
The agency's original wording
Hazard
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
30 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono floor. Model Number: 11327700.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2643-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.