Events

Rappel de Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

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-00586-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-12
  • 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-00586-1
  • 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 following issues have been identified which may result in additional patient scanning & therefore additional radiation doses. there have been no reports of injuries as a result of these issues;- scan length changes with a change in the field of view (fov);- the doseright algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kvp or 120 kvp surview is used. this will result in a mas value for the scan that is higher than suggested when using a 100 kvp or 140 kvp surview. (note: the reported mas and ctdi values are correct for all scans & surviews);- wrong scan time estimation due to incorrect intergration time causes the surview scan near 184mm &135mm may result in unexpected scan start positions; &- there may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is also not possible.
  • Action
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

Manufacturer

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