Events

Retiro De Equipo (Recall) de O-Arm 1000 Imaging System (3rd Edition)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty 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
    RC-2018-RN-00093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00093-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    In july 2017, medtronic navigation rolled out routine sw update 3.2.1. this update is in response to customer complaints and addresses several known software anomalies. the software anomalies were reported to affect system behaviour that include the following issues:• inability to power the system after shutdown• system stays in standalone mode• image reconstruction• system/pendant bootup• dose display/report• gantry motion• network communication• system shutdown• early termination of 3d spinin 3 instances, these software anomalies have resulted in aborting use of the o-arm and reschedule of surgeries after incision.
  • Acción
    Medtronic will be in contact with customers to arrange for the software update to be installed.

Device

O-Arm 1000 Imaging System (3rd Edition)
  • Modelo / Serial
    O-Arm 1000 Imaging System (3rd Edition)ARTG Number: 168216 ((Medtronic Australasia - X-ray system, diagnostic, fluoroscopic, general-purpose, application program software))
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA