Events

Rappel de ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus 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 Philips Electronics Australia 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-2014-RN-00405-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-01
  • 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-2014-RN-00405-1
  • 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
    Philips healthcare received a report from the field about an adac vertex plus system. during clinical use in the relative 180 degree configuration of the detector heads, the radius drive belt in the superior positioned head slipped off the idler pulley, allowing the detector head to drift down slowly (approximately 1 cm per minute) towards the patient. this resulted in the operator having to perform an emergency removal of the patient from the system. there have been no reports of serious injury or death as a result of this situation.
  • Action
    Hospitals are requested to cease use of "Relative 180 degree SPECT" and "pinhole collimator" procedures until the implementation of the correction. Philips will replace the two radius drive belts and idler pulleys to correct the problem.

Device

ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA