Events

Rappel de BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT 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-2017-RN-00327-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-06
  • 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-00327-1
  • 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 detector braking systems may be rendered ineffective resulting in one or both detectors moving to their mechanical limit. in the case of this kind of failure, the detector motion cannot be halted using normal operator intervention (e-stop, collimator contact sensor activation). the detector(s) may move down onto the patient or operator, potentially resulting in entrapment and/or serious injury or death. any brightview, brightview x or brightview xct where components on the braking system have been serviced is potentially affected. systems that were serviced and received a complete brake assembly are not affected by this issue.
  • Action
    Customers are advised to immediately discontinue use of the system until Philips Service has undertaken the inspection of the system. The system can be returned for clinical use if the system brakes pass inspection. If the system brakes fail inspection, the system will be returned for clinical use once the correction is implemented.

Device

BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nucl...
  • Modèle / numéro de série
    BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT systems)Affected component(s) or subsystem(s):Radius DrivePart Numbers: 453560304611, 453560312361, 453560303641Tangent DrivePart Numbers: 453560304611, 453560312361, 453560303761Roll DrivePart Numbers: 453560313601, 453560303781, 453560313881ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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