Events

Rappel de TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video 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 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-2015-RN-01250-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-24
  • 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-2015-RN-01250-1
  • 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 has received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determinedthe root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly, the spring arm of the lighting system can descend over time, and eventually fall from the central axis. when the snap ring has been installed properly, the potential for the lighting system to fall does not exist.
  • Action
    Hill-Rom is providing users with work around instructions to follow as an interim measure. Hill-Rom will be inspecting affected units and providing additional labelling as a permanent measure.

Device

TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems
  • Modèle / numéro de série
    TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video SystemsMultiple products and serial numbers affectedARTG Numbers: 200921, 170219 and 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd