Events

Rappel de TruVidia Wireless Receiver

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Trumpf Med Aust 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-2018-RN-00075-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-24
  • 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-2018-RN-00075-1
  • 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
    Trumpf medical discovered that the radiated emission from the truvidia wireless receiver is above the normative accepted limits. it is unlikely, but possible, that the radiated emission may interact with other devices in the operating room, which may cause other devices to not function properly. the frequency of interference and associated risk will be dependent upon the immunity of the other devices for radiated emissions and nature of the failure mode of the operating room equipment being used at the time.
  • Action
    Trumpf Medical is advising users that an upgrade of the affected components will be completed as a permanent correction. If users suspect that the device may be interacting with other devices in the operating room, switch off the wireless receiver (ensure the receiver is switched off, it is not sufficient to switch off the camera or control unit).

Device

TruVidia Wireless Receiver
  • Modèle / numéro de série
    TruVidia Wireless Receiver Model Number: 1940747Serial Number: 102584474 to 103214022ARTG Number 274674
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd