Events

Retiro De Equipo (Recall) de Nordic Neuro Lab Headphones used with Siemens MRI systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2017-RN-00761-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-19
  • 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-2017-RN-00761-1
  • 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
    The manufacturer nordic neuro lab has been notified that a set of the headphone slim (hps) heated on the 1.5t scanner during an mri spinal examination, causing damage to the hps headphones. during a patient scan, the hps headphones had become warm and hence, uncomfortable for the patient to wear. subsequent investigation of the affected product showed clear indications of overheating. neither the patient nor the operator were injured. however, the headphone was sufficiently heated to potentially cause injury.
  • Acción
    Siemens is advising users to immediately stop using the affected headphones until further notification. Users are to use the standard auditory system from the scanner vendor (pneumatic) until resolution of the matter. Users who require high audio quality are requested to contact Siemens customer service for information on the possibility to receive a set of NNL Ear Plugs as a temporary solution until the matter is resolved.

Device

Nordic Neuro Lab Headphones used with Siemens MRI systems
  • Modelo / Serial
    Nordic Neuro Lab Headphones used with Siemens MRI systemsHeadphones (HP)Catalogue Numbers: HP-1.3-20169-685 to HP-1.3-2016-693 Serial Numbers: 150694 to 150701Headphones Slim (HPS)Catalogue Numbers: HPS-1.0-2015-001 to HPS-1.0-2016-051Serial Numbers: 160052 to 160074ARTG Number: 186703
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA