Events

Retiro De Equipo (Recall) de Carestream DRX Evolution with DIRECTVIEW Software

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
    19019
  • Fecha de inicio del evento
    2015-08-26
  • 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 identified a software issue that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (eg. radio opaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors.
  • Acción
    Software to be upgraded

Device

Carestream DRX Evolution with DIRECTVIEW Software
  • Modelo / Serial
    Model: Carestream DRX Evolution with DIRECTVIEW Software, Affected: Versions 5.6 & greater, and V5.7 with DR LLI Auto Stitich
  • Manufacturer
    Carestream Health Inc

Manufacturer

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