Siemens Medical Solutions USA, Inc recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention…

Recall date

May 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2019-2025

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.