Events

Retiro De Equipo (Recall) de Nexframe Stereotactic

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Image Guided Neurologics, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    45912
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0849-2008
  • Fecha de inicio del evento
    2007-10-04
  • Fecha de publicación del evento
    2008-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66464
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stereotaxic instrument - Product Code HAW
  • Causa
    Sterilty (package integrity) compromised: some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. the seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.
  • Acción
    On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).

Device

Nexframe Stereotactic
  • 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
    Neurological Devices
  • 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
  • Manufacturer
    Medtronic Image Guided Neurologics, Inc.

Manufacturer

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)
    Medtronic plc
  • 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