Events

Rappel de MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)

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-2016-RN-00943-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-15
  • 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-2016-RN-00943-1
  • 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 two bolts that attach the clamping plate to the lateral shaft may break. this may cause the c-arm to float freely. depending on the orientation of the free-floating c-arm and any other forces applied to it, the c-arm could move laterally forward, slide out of its bearings and then possibly sag. the sagging c-arm can strike a patient or operator. however, the probability of this occurring is rare. there have been no reports of injury associated with this event.
  • Action
    Philips is advising users to be aware of the issue. If the C-arm moves in an unexpected manner, users should contact Philips immediately. Philips will be implementing a repair of the C-arm as a permanent correction. This action has been closed-out on 28/06/2017.

Device

MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)
  • Modèle / numéro de série
    MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)MultiDiagnost ElevaProduct Code: 708032MultiDiagnost Eleva with Flat DetectorProduct Code: 708034MultiDiagnost ElevaProduct Code: 708036MultiDiagnost Eleva with Flat DetectorProduct Code: 708037 MultiDiagnost Eleva with Flat DetectorProduct Code: 708038ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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