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

Recalled July 26, 2017 · FDA recall Z-2686-2017 · Siemens Medical Solutions USA

Hazard

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. · FDA Class II

Units

97 distributed worldwide, 12 distributed in United States

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →