Z-2020-2025Class II

interventional fluoroscopic x-ray system

Name: Z-2020-2025 interventional fluoroscopic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-05-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-05-15 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of interventional fluoroscopic x-ray system on 2025-05-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2020-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-15
Posted: 2025-06-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: interventional fluoroscopic x-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA 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 the current software version of the affected system.
Distribution: Worldwide.
Product codes and lots: 4056869063317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2020-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2019-2025	Class II	Ongoing	FDA Mandated	2025-07-09	2025-06-27
Z-2020-2025	Class II	Ongoing	FDA Mandated	2025-07-09	2025-06-27
Z-2021-2025	Class II	Ongoing	FDA Mandated	2025-07-09	2025-06-27
Z-2022-2025	Class II	Ongoing	FDA Mandated	2025-07-09	2025-06-27

Product code OWB

K241572Class IIARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. / cleared 2024-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)