Events

Rappel de Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media)

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-2015-RN-00960-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-29
  • 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-2015-RN-00960-1
  • 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
    When actively deselecting a fused reference dataset in content manager (the default setting is “selected”), a contained point, object or trajectory may appear shifted and/or distorted in the subsequently used brainlab navigation or planning software. if a reference dataset is deselected and the error occurs, the magnitude of shift or distortion varies, depending on the differences between the two datasets. therefore, for some cases, the shift or distortion will be clearly visible when the plan is used in a brainlab planning or navigation system. however, a shift could also be non-obvious. if a shift or distortion occurred and was not detected during review of the data, the deviation of the information displayed in the brainlab planning or navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
  • Action
    Brainlab will provide a software solution to prevent the described scenario from occurring starting February 2016. In the interim, users are advised not to deselect individual datasets where a Point, Object or Trajectory was planned in. If users are unsure in which dataset a Point, Object or Trajectory was planned, do not deselect any content from the plan. Open the entire plan instead. Before patient treatment, always review the plausibility of all information input to and output from the device.

Device

Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans...
  • Modèle / numéro de série
    Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media)Product Version NumbersContent Manager (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0) Patient Browser (versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.1.0) DICOM Viewer (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0) ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd