FDA recall, , Moderate risk
Siemens ARTIS Icono Ceiling
The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, recalled the ARTIS icono ceiling, model number 11328100, because some screws that keep the monitor attached to the Display ceiling suspension (DCS Fix XL) may gradually loosen over time. The FDA added the recall to its Enforcement Report on July 1, 2026, and the company began the recall on June 8, 2026.
The recall affects 57 units distributed in California, Georgia, Iowa, Indiana, Louisiana, Missouri, North Carolina, New York, Pennsylvania and South Carolina.
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?
Affected if its model number matches.
ARTIS icono ceiling.
- Model
- 11328100
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Georgia, Iowa, Indiana, Louisiana, Missouri, North Carolina, New York, Pennsylvania, South Carolina.
- 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
- 99224
- Recall number
- Z-2648-2026
- Quantity recalled
- 57 units
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
