Events

Rappel de Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia 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-2013-RN-00716-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-17
  • 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-2013-RN-00716-1
  • 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
    It has been detected that the pointer cap with the engraved cross hairs may become loose even when only a moderate force is applied to the pointer cap. due to the manufacturing tolerances specified the force to loosen the pointer cap may vary, depending on the individual pointer cap and aluminium pointer rod assembly. if this occurs, most likely the pointer cap will detach completely, rendering the target pointer no longer usable. in a scenario that the pointer cap would loosen but not detach completely, a shift of the pointer cap of up to 2mm might remain unnoticed. since the device is used for calibration and quality assurance of patient positioning technologies for radiation therapy treatments at a linear accelerator, this scenario might degrade the accuracy of the positioning solution used.
  • Action
    Brainlab is requesting users to inspect stock and quarantine affected devices. Replacement stock will be provided to affected customers.

Device

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient posit...
  • Modèle / numéro de série
    Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)Product Number: 43410Serial Number: 1223012002, 1223012007, 1223012008ARTG Number: 121226
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd