Events

Retiro De Equipo (Recall) de MERGE PACS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MERGE HEALTHCARE INCORPORATED.

¿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
    127903
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    This recall has been initiated due to merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. pacs 6.5.6 introduced the feature to be able to display foreign presentation states however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study they would also be shown if available on the prior comparison studies.

Device

MERGE PACS
  • Modelo / Serial
    Model Catalog: MERGE PACS (Lot serial: 6.6.1); Model Catalog: MERGE PACS (Lot serial: 6.5.5); Model Catalog: MERGE PACS (Lot serial: 6.6.0); Model Catalog: MERGE PACS (Lot serial: 6.6.1.1); Model Catalog: MERGE PACS (Lot serial: 6.6.2); Model Catalog: MERGE PACS (Lot serial: 6.5.9); Model Catalog: MERGE PACS (Lot serial: 6.5.6); Model Catalog: MERGE PACS (Lot serial: 6.5.7); Model Catalog: MERGE PACS (Lot serial: 6.5.8)
  • Descripción del producto
    Merge PACS
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED