Siemens Medical Solutions USA, Inc recalls Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material…

Recall date

July 30, 2019

Source

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

Recall number

Z-2367-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI

Why it was recalled

Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts

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 zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego 10848283 ArtisQ.zen ceiling 10848354 Product Usage: 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, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. The Artis family can also support the acquisition of position triggered imaging for spatial data synthesis.