Events

Rappel de Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)

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-01541-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-21
  • 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-01541-1
  • 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 a software issue causing pet reconstructions to fail intermittently. it was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. this error has been found to occur in two scenarios resulting in acquisition data that will not be able to be reconstructed and will therefore be unusable: 1) when the system operator cancels an acquisition2) couch position requests within the software sequence were delayed a. the error occurs intermittently, but has been found to occur more frequently when the gantry’s network is heavily loaded with multiple retrospective reconstructions running in parallel. b.The error manifests to the technologist by an error message and failed status on the reconstruction monitor and the error message “result {0} failed to reconstruct” on the acquisition workflow window during reconstruction after the patient scan has been completed.
  • Action
    It is recommended that the technologist follow the Warning provided in the Instructions for Use - System Information for Ingenuity TF 459800079321 Rev B, Section 2 Safety Guidelines, pg 2-17 and that the patient remains in the original scan position until reconstructed images are verified. Philips will be releasing a correction for this issue. A Philips Field Service Engineer will contact users to schedule the update.

Device

Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)
  • Modèle / numéro de série
    Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)Model: 882442ARTG 292543
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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