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Siemens Medical Solutions USA, Inc recalls AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography syste
Recalled November 23, 2016 · FDA recall Z-0603-2017 · Siemens Medical Solutions USA
Hazard
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. · FDA Class II
Units
4,657 systems Worldwide
Sold at
US Nationwide Distribution.
Description
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Product
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen 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 →