Siemens Medical Solutions USA, Inc recalls Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and bi…

Recall date

February 3, 2017

Source

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

Recall number

Z-2686-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY

Why it was recalled

Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.

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,x-ray system, angiographic Artis zee 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 zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis