Events

Rappel de Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT X-ray system)

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-2012-RN-00812-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-08-08
  • 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-2012-RN-00812-3
  • 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 following issues have been identified with this product:1. the current system design of software version 4.0.0.Xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for ct brain perfusion scanning, which previous versions did. however, the current version does have the dose check (nema xr-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable dose check after entering their credentials and password 2. when service providers gain a remote connection to the scanner, the scanner does not notify the user that remote access of the system is in effect3. when the interventional biopsy protocol is used, the manual button is enabled on the ct control, but when the user presser the "go" button on the gantry, it may produce multiple scans4. the table and the gantry could get close enough to each other (<25mm apart) which poses the risk of 'pinching' a patient's or technologist's finger.
  • Action
    Philips is providing a software update to permanently correct the issues.

Device

Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT...

Manufacturer

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