Events

Retiro De Equipo (Recall) de O-ARM 1000 IMAGING SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF CANADA LTD..

¿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
    76354
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-01-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential failure in the braking system that controls the o-arm gantry's vertical movement. this potential failure exists when the o-arm gantry is in a raised position and could result in an uncontrolled descent when the up/down button is released. the gantry would stop when coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel (which could include contact with the patient and/or protruding instrumentation within the bore of the system). if this failure were to occur it would have the potential to result in serious injury or death to the patient or injury to users or both. this potential failure has no impact on the amount of radiation emission delivered by the system.

Device

O-ARM 1000 IMAGING SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 9732719 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    O-ARM IMAGING SYSTEM
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • 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
    HC