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Siemens Medical Solutions USA, Inc recalls AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed
Recalled February 14, 2018 · FDA recall Z-0508-2018 · Siemens Medical Solutions USA
Hazard
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards. · FDA Class II
Units
265 units
Sold at
US Nationwide Distribution
Description
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Product
AArtis Q/ Q.Zen biplane Artis zee biplane 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →