Device Recall AXIOM Artis Angiographic XRay System
Modèle / numéro de série
AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC model number 7728350, AXIOM Artis TA model number 7007755, AXIOM Artis dFC model number 7412807, AXIOM Artis dFC-MN model number 7727717, AXIOM Artis dBC model number 7728392, AXIOM Artis dTC model number 7413078, AXIOM Artis dFA model number 7555373, AXIOM Artis dBA model number 7555357, AXIOM Artis dTA model number 7008605, AXIOM Artis dMP model number 7555365. Software versions VB11K and VB22G.
Nationwide. The product was shipped to medical facilities in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL,IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI and WV.
Description du dispositif
AXIOM Artis X-ray systems running software versions VB11K and VB22G