Siemens Medical Solutions USA, Inc recalls Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imagi…

Recall date

January 12, 2018

Source

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

Recall number

Z-1148-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.

Why it was recalled

Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.

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 one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one 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.