Events

Retiro De Equipo (Recall) de SYSTEM DI-60 MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SYSMEX CANADA 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
    51870
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2018-01-23
  • 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
    Sysmex america inc. has been made aware of a software defect on versions 6.0.1 and 6.0.2 running on the cellavision dm-series and sysmex di-60 that may cause comments to not be transmitted to the laboratory information system (lis). if all the following three conditions are met the comments will not be transmitted from the cellavision software to the lis: 1. the analyzer system computer server and remote review software installed is on version 6.0.1 or 6.0.2 and 2. the workflow with multiple slides for blood samples is used and 3. wbc rbc and plt comments are added to the last slide after it has been already signed.

Device

SYSTEM DI-60 MAIN UNIT
  • Modelo / Serial
    Model Catalog: CC286297 (Lot serial: 60044 - 60965); Model Catalog: BC188562 (Lot serial: NA)
  • Descripción del producto
    SYSTEM DI-60 MAIN UNIT;SYSTEM DI-60 REMOTE REVIEW SOFTWARE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    HC