Siemens Medical Solutions USA, Inc recalls Artis Zee (material # 10094135, 10094137, 10094141) - Produc
Recalled Product
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: 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 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 and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Hazard / Issue
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Issued by
FDA
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