Recall Z-2020-2025— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2020-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-15

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-05-15. It names one FDA 510(k) clearance: K241572. Product: interventional fluoroscopic x-ray system. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-05-15
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc.·cleared 2024-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.