Siemens Medical Solutions USA, Inc recalls ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of…

Recall date

January 24, 2020

Source

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

Recall number

Z-1340-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

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 Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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 AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.