FDA-Device2026-07-08Class IIPROCESSING DEFECT
Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
What this means
Siemens Medical Solutions USA is recalling the ARTIS icono ceiling model 11328100 due to a potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits. This affects 119 units distributed nationwide.
- Check if your facility has this model (11328100) by serial number.
- Contact Siemens Medical Solutions USA for guidance on remediation or replacement.
- Do not adjust the detector lift height to extreme positions until you receive instructions from the manufacturer.
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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
119 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono ceiling. Model Number: 11328100.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2642-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
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