Siemens Medical Solutions USA, Inc recalls AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems d…

Recall date

November 1, 2016

Source

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

Recall number

Z-0603-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution.

Why it was recalled

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

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

What was recalled

AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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 zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.