Events

Retiro De Equipo (Recall) de SDC HD CAPTURE RECORDER W/PRINTER

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

¿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
    50937
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-11-04
  • 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
    Stryker endoscopy was aware that the sdc hd picture/video capture device would not be able to assign the correct time/date stamp for saved files after december 31st 2009. on january 1st 2010 the system date for all sdc hd units would re-start from october 1st 2001 and begin incrementing from that point onwards. this event would not affect how pictures or videos were captured using sdc hd during surgery however the system date would be incorrect and users would not be able to correct this issue without a software upgrade.

Device

SDC HD CAPTURE RECORDER W/PRINTER
  • Modelo / Serial
    Model Catalog: 240-050-890 (Lot serial: ALL LOT NUMBERS); Model Catalog: 240-050-888 (Lot serial: ALL LOT NUMBERS)
  • Descripción del producto
    SDC HD Capture Device
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC