Events

Retiro De Equipo (Recall) de ASP 300 TISSUE PROCESSOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA BIOSYSTEMS NUSSLOCH GMBH.

¿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
    53292
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-08-04
  • 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
    One complaint was received where the remote alarm of an affected instrument did not alert the customer properly of an error that occurred during processing. a review meeting was held by the manufacturer to determine that the drawing of the remote alarm cable does have an error which led to a malfunction of the remote alarm. cables with this error were used since april 24 2013 in production. a shiphold of the asp200s/asp300s was initiated on july 13 2015. within this time period 901 instruments were distributed globally with the affected cables. the affected devices have an incorrect internal wiring to the remote alarm plug which can cause the remote alarm to not function correctly in the case of an instrument failure.

Device

ASP 300 TISSUE PROCESSOR
  • Modelo / Serial
    Model Catalog: ASP300S (Lot serial: 5818); Model Catalog: ASP200S (Lot serial: 5818); Model Catalog: ASP300S (Lot serial: 5687); Model Catalog: ASP200S (Lot serial: 5687); Model Catalog: ASP300S (Lot serial: 5686); Model Catalog: ASP200S (Lot serial: 5686); Model Catalog: ASP300S (Lot serial: 5685); Model Catalog: ASP200S (Lot serial: 5685); Model Catalog: ASP300S (Lot serial: 5618); Model Catalog: ASP200S (Lot serial: 5618); Model Catalog: ASP300S (Lot serial: 5593); Model Catalog: ASP200S (Lot serial: 5593); Model Catalog: ASP300S (Lot serial: 5541); Model Catalog: ASP200S (Lot serial: 5541)
  • Descripción del producto
    ASP200S/ASP300S TISSUE PROCESSOR
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH