ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
FDA device recall Z-1653-2026 · posted 2026-04-07 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice, dated March 9, 2026, to all affected customers.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- U.S. 758, OUS 2077
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2026-03-10
- Date posted
- 2026-04-07
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |