Siemens Medical Solutions USA, Inc recalls Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagn…

Recall date

March 19, 2015

Source

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

Recall number

Z-1445-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide

Why it was recalled

potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

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 Q/ Q zen systems; Artis Q/ Q zen systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.