Events

Rappel de E.CAM or Symbia E System: Rear Casters of the Collimator Cart

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 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-00855-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-01
  • 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-00855-1
  • 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 rear casters of the collimator cart may become loose and under certain circumstances result in the cart tipping towards the operator. this problem occurs when two conditions are present: 1. the caster has insufficient clamping force and 2. the affected caster passes over a low spot in the floor. if both conditions exist, it is possible the caster will dislodge from the bottom of the cart, allowing the cart to tip backwards toward the operator.
  • Action
    End users are advised that they can continue to use your system while waiting for the field correction to be scheduled and performed. However, if you suspect a caster is loose, as indicated by shaking while the cart is in motion, discontinue use of the collimator cart and notify your local Service representative. A retention bracket will be installed on all affected devices to correct the problem. This action has been closed-out on 24/05/2016.

Device

E.CAM or Symbia E System: Rear Casters of the Collimator Cart
  • Modèle / numéro de série
    E.CAM or Symbia E System: Rear Casters of the Collimator CartCatalogue numbers: Collimator Carts 7760908, 7760882ARTG number: 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA