Device Recall Siemens Axiom Artis zeego systems

  • Modèle / numéro de série
    Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.
  • Description du dispositif
    Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration || Angiographic x-ray system
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Société-mère du fabricant (2017)
  • Source
    USFDA