interventional fluoroscopic x-ray system
FDA device recall Z-2020-2025 · posted 2025-06-27 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 the current software version of the affected system.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Distribution
- Worldwide.
- Date initiated
- 2025-05-15
- Date posted
- 2025-06-27
- Location
- Malvern, PA
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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 |