Events

Rappel de Shimadzu Ceiling Type X-ray Tube Support

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Shimadzu Medical Systems Oceania 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-2017-RN-00698-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-08
  • 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-2017-RN-00698-1
  • 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 x-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. it was found that, extremely infrequently, a crack may occur over time on the tube holding shaft near the base of the tube mounting flange. if these cracks occur and then increase in size, the tube mounting flange may separate from the tube holding shaft. should separation of the tube mounting flange from the tube holding shaft occur, there is a risk that the x-ray tube assembly may come into contact with the patient or operator.
  • Action
    Shimadzu will be contacting users to arrange for installation of additional protection parts to the x-ray tube support by a Shimadzu technical support engineer, to prevent the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. In the interim, users are advised to take the following actions: - Carry out daily inspection of the CH-200/CH-200 M as per instruction manual. - If abnormalities are found, such as rattling and/or deviation of the light irradiation field, discontinue use and contact the service representative. - When rotating the X-ray tube device, control the movement of the X-ray tube assembly to avoid a forceful stop at the end of the rotational movement. In the unlikely event that cracks have already occurred, a forceful stop at the end of rotational movement may accelerate cracking.

Device

Shimadzu Ceiling Type X-ray Tube Support

Manufacturer

Shimadzu Medical Systems Oceania Pty Ltd