Events

Rappel de BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT)

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-2014-RN-01225-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-27
  • 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-2014-RN-01225-1
  • 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 the following anomalies that give rise to a potential hazard of unexpected contact between the detector and the patient: 1)following a cardiac scan and when using smartstep to set-up the camera for a relative 180 procedure, it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. this issue only affects brightview xct systems.2) during a patient spect lung acquisition, the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degree position. however, in the middle of a clinical scan acquisition, the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degree to the 240 degree may take approximately 7 seconds.There have been no reports of patient injury due to either of these issues to date.
  • Action
    Philips is advising the customer/user to perform the work-around identified in the customer communication prior to the implementation of the permanent correction, to avoid contact between the detector and the head holder. Also, they are advised to monitor the patient during all system motions and to know locations of the multiple E-Stop button(s) to halt all system motions, if required. The correction will consist of the installation of BrightView Family software version 1.2.4/2.5.4.

Device

BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (...
  • Modèle / numéro de série
    BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT) ARTG number: 117440
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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