Events

Rappel de Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carestream Health Australia Pty 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-00501-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • 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-00501-1
  • 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
    Carestream health has identified a software issue related to image orientation. if the image suite software receives a computed tomography (ct) or magnetic resonance (mr) image with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the left (l) and right (r) and anterior (a) and posterior (p) overlay text will be displayed opposite. that is, the left side is marked r and the right marked l and the anterior marked p and the posterior marked a. this could result in delays in a misdiagnosis or improper patient care.There has not been any diagnosis errors reported.
  • Action
    Carestream Health Australia will contact the affected customers to update the software on the device to correct this issue. In the interim, until the software update has occurred, customers who use Image Suite for CT or MR images should make users aware of the problem and take additional steps to check correct orientation of any markers. A review of past patients’ results is recommended at the discretion of the clinical director/radiologist.

Device

Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)I...
  • Modèle / numéro de série
    Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)ARTG number: 172338
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd