Siemens Medical Solutions USA, Inc. recalled the ARTIS icono floor imaging system on May 20, 2026, according to the FDA. The device poses a potential loss of movement capability when adjusting detector lift height limits. Owners should contact Siemens for remedy details.
How to tell if you have it
- Brand: Siemens
- Product: ARTIS icono floor
- Model Number: 11327700
- UDI-DI: 4056869149325
- Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067
- Units affected: 30
- Distribution: US Nationwide
The hazard
The recall addresses the potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026), and Siemens ARTIS pheno and Icono Biplane X-Ray Recalls (March 10, 2026). Other recent recalls of similar products include Philips Azurion 3 M15 System Recall (Jan. 26, 2026), Philips Azurion 7 B20 System Recall (Jan. 26, 2026), and Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026).