FDA recall, , Moderate risk
Siemens Artis Pheno and Artis Icono Biplane Systems
ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, is recalling ARTIS pheno and ARTIS Icono biplane, floor and ceiling systems. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
The recall began on March 10, 2026, and was added to the FDA's Enforcement Report on April 7, 2026, with nationwide distribution in the U.S. The company recalled 758 units in the U.S. and 2077 outside the U.S.
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 and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ARTIS pheno and ARTIS Icono biplane, floor and ceiling
- Model number
- 10849000
- 11327600
- 11328100
- 11327700
- UDI-DI
- 4056869046877
- 4056869063317
- 4056869295923
- 4056869149325
Recall details
- Company began the recall
- Sold in
Worldwide - 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
- 98675
- Recall number
- Z-1653-2026
- Quantity recalled
- U.S. 758, OUS 2077
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
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
