Events

Rappel de Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens 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-00992-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • 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-00992-1
  • 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
    Loss of images - if an automatic ris worklist update is performed while a patient is already selected for examination, the subsequently acquired images of this patient might get lost under certain circumstances and cannot be recovered. this malfunction is not detectable to the user during the examination. only after the patient study is opened in the “examined patients” list, the user will be able to recognize that the acquired images are not available and irreversibly lost.Incorrect labels and annotations - under certain circumstances the image label (l, r) and annotations are displayed incorrectly after images have been sent to pacs or hardcopy/filming.
  • Action
    Siemens are working on a software update to correct both malfunctions. In the interim Siemens is providing the following work around instructions: - To avoid the potential risk of lost images Siemens is advising their customers to disable the automatic RIS worklist update and perform this procedure manually. - To ensure the correct orientation of images Siemens recommends to always use lead letters to indicate patient orientation on the x-ray image. This action has been closed-out on 06/06/2016.

Device

Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C
  • Modèle / numéro de série
    Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10CARTG numbers – 102184, 102182
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA