Events

Retiro De Equipo (Recall) de Carestream PACS Client Workstation

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Carestream Health Inc.

¿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
    15496
  • Fecha de inicio del evento
    2013-10-16
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • Causa
    Carestream health has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios. this problem occurs infrequently and only when all of the following conditions are met:, 1) the version installed is v11.3.2 or v11.3.2.4 or v11.4, 2) the exam type is from multi-slice modalities, 3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images., 4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Acción
    Software to be upgraded

Device

Carestream PACS Client Workstation
  • Modelo / Serial
    Model: Catalogue numbers: 1308519, 1530633, 1467067, 1405794, 8171837, Affected: Software Versions: 11.3.2.0 / 11.3.2.4 / 11.4
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    NZMMDSA