medical Class II Updated 2019-05-22

Siemens Medical Solutions USA, Inc recalls Artis Q (material 10848280, 10848281, 10848282) - Product Us

Recalled Product

Artis Q (material 10848280, 10848281, 10848282) - 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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number 105121 105122 105123 105124 105125 111129 111130 111127 111106 111128 123245 123246 123240 123239 123244
View official government recall

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