medical Class II Updated 2019-05-22

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235
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