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Siemens Medical Solutions USA, Inc recalls Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imagi
Recalled April 6, 2016 · FDA recall Z-1282-2016 · Siemens Medical Solutions USA
Hazard
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc. · FDA Class II
Units
1 angiography system
Sold at
Nationwide Distribution to Michigan only
Description
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Product
Artis One, Interventional, Fluoroscopic, x-ray system 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 Artis 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 patient extremities.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →