Device Recall XVI R4.5 Xray Volume Imaging System

  • Modèle / numéro de série
    152433, 152019, 151176, 152248, 152262, 152454, 105941, 151802, 152427, 151628, 151362, 152207, 151545, 151566, 152271, 152425, 152452, 152491, 151808, 152163, 152331, 151443, 151955, 152585, 152522, 151514, 151791, 151430, 151931. 105984, 151412, 152388, 151616, 151141, 152303, 151892, 151785, 152358, 152223, 152305, 152468, 151260, 152469, 152481, 152601, 152356, 152175, 152365, 152177, 152257, 151952, 152353, 152359, 152362, 152352, 152371, 152370, 151942, 151820, 151770, 151864, 151396, 152448, 151954, 151076, 151309, 152103, 152301, 151634, 151793, 152210, 152211, 151080, 152373, 152222, 152158, 152392, 151684, 152530, 152536, 151168, 151839, 151156, 151155, 151157, 152117, 151710, 152308, 152307, 152504, 151683, 151764, 151885, 152432, 151812, 152549.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico
  • Description du dispositif
    Elekta Synergy XVI 4.5 and R4.6 || To be used as part of radiation therapy treatment process.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Société-mère du fabricant (2017)
  • Source
    USFDA