Events

Rappel de BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)

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-00787-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-14
  • 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-00787-1
  • 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
    During a non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan. a certain set of conditions identified in the customer letter are required to create the situation. there have been no reports of any injuries associated with this issue. however, users are reminded to ensure patients are observed closely at all times, and the e-stop is activated to prevent contact with the patient, if required.
  • Action
    Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.

Device

BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear...
  • Modèle / numéro de série
    BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)Model numbers: 882478, 882482ARTG numbers: 117642, 17440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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