Recall Z-2020-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
| Date | Jun 27, 2025 (initiated May 15, 2025) |
| Status | Open, Classified |
| Reason | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Siemens Healthineers sent customers a Customer Advisory Notice dated May 15, 2025 informing customers of a potential issue with ARTIS pheno and ARTIS icono systems with the following model numbers: ARTIS pheno 10849000, ARTIS icono biplane 11327600, ARTIS icono ceiling 11328100, ARTIS icono floor 11327700; due to in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose and appropriate software update will be implemented, based on |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) Siemens Medical Solutions USA, Inc., Oct 22, 2024 |