Z-1653-2026
Class II · Ongoing
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 20260310
- Firm location
- Malvern, PA, United States
Product description
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.