Medtronic Image Guided Neurologics, Inc.

  • Dirección del fabricante
    Medtronic Image Guided Neurologics, Inc., 2290 W Eau Gallie Blvd, Melbourne FL 32935-3133
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    Lot #s: 070380, 061248, 070175, 070375, 070621, 070825, 070634, 6510106A, 046510106A, 46515606, 046520506A, 046521606A, 046523406A,  61262, 70160, 070326, 070171, 60215, 070719, 070378, 070169, 070320, 70543, 070172, 610127, 610133, 70169, 61208, 70313, 51067, 60174, 60215 60578, 046510106C, 70153, 60175, 046510106F, 46534905, 046520506B, 070164, 070633, 070376, 070375, 070538, 070724, 070376, 61264, 61212,  070855, 070854, 070830, 070863, 070726, 070628, 60542, 60573, 60574, 60659, 61262, 70312, 070379, 61216, 70312, 070628, 070726, 61264, 070723 070166, 070629, 070164, 070379, 070856, 60583, 61237, 61238, 606110, 70312, 070159, 70174, 70144, 070160, 70375, 070631, 070825, 070726, 070628, 070863, 61208, 70145, 610134, 70321, 61247, 70315, 70334, 070724 070720, 070602, 070326, 070602, 070631, 070325, 070719, 70123, 70160,  046502607B, 070165, 070826, 046505707B, 60434, 60433, 046510106E
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.
  • Descripción del producto
    Nexframe¿ Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, || DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, || DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, || DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, || DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota