Events

Rappel de Nordic Neuro Lab Headphones used with Siemens MRI systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00761-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00761-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA