Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carestream Health Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00501-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00501-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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