Siemens Medical Solutions Usa, Inc: Interventional Fluoroscopic X-ray System

Recall Summary Siemens Medical Solutions is recalling the ARTIS icono ceiling X-ray system (Model 11328100) distributed nationwide because the detector may lose movement capability after being adjusted to its highest or lowest position. This is a Class II recall affecting medical facilities across the United States.

Recalling firm
Siemens Medical Solutions USA, Inc
Product
ARTIS icono ceiling. Model Number: 11328100.
Reason
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-05-20
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/08b8b908-cac9-49f5-83d7-50ecadca0d66