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Siemens Medical Solutions USA, Inc recalls Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated ang
Recalled September 6, 2017 · FDA recall Z-3095-2017 · Siemens Medical Solutions USA
Hazard
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. · FDA Class II
Units
986 units in USA
Sold at
Nationwide Distribution
Description
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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 AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM 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 →