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Open, Classified

interventional fluoroscopic x-ray system

FDA Recall Z-2021-2025 · Posted 2025-06-27

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-05-15

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. · 2024-10-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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