Events

Retiro De Equipo (Recall) de Medtronic O-arm O2 Imaging System X-ray system

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medtronic Navigation 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
    20411
  • Fecha de inicio del evento
    2016-07-26
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Causa
    The o-arm® system requires updates in order to maintain compliance with applicable performance standards. specifically,, 1.Certain aspects of the technical information in the instructions for use document require clarification., 2.Radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements., 3.The o-arm system x-ray technique factor display accuracy related to ma might not be compliant to the system specifications.
  • Acción
    Software to be upgraded

Device

Medtronic O-arm O2 Imaging System X-ray system
  • Modelo / Serial
    Model: B1-700-02000, B1-700-00027 & B1-700-00028, Affected: , Software version: Software Version 3.1.x, Software Version 3.2
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • 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
    NZMMDSA