FDA recall, , Moderate risk
Siemens ARTIS Icono Biplane, Ceiling and Floor
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, began a recall on May 20, 2026, for ARTIS icono floor, ARTIS icono biplane, and ARTIS icono ceiling due to a potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. The recall was added to the FDA's Enforcement Report and classified on July 1, 2026, and was in the FDA's weekly enforcement report on July 8, 2026. Distribution was US Nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 models
Affected if its model number is listed.
ARTIS icono biplane.
- Model
- 11327600
ARTIS icono ceiling.
- Model
- 11328100
ARTIS icono floor.
- Model
- 11327700
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99079
- Recall numbers
- Z-2641-2026 to Z-2643-2026
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
