Events

Rappel de BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16

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-2018-RN-00049-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-15
  • 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-2018-RN-00049-1
  • 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
    Philips has identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.
  • Action
    Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange. Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system. It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera. It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU. Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.

Device

BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
  • Modèle / numéro de série
    BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16Product Number - 8823500 Precedence 16Product Number - 882351 Precedence 6 SliceProduct Number - 882478 BrightView X Product Number - 882480 BrightView SPECTProduct Number - 882482 BrightView XCTARTG Number: 117440 (Philips Electronics Australia Ltd - SPECT/CT diagnostic imaging system)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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