Events

Retiro De Equipo (Recall) de ASP6025 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
    106920
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-06
  • 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
    The affected devices have incorrect labelling with regard to the specified voltage for the alarm connectors on the rear side of the instrument. the current incorrect labels specify 125va.C as maximum voltage. it has been identified that if someone connects such 125va.C to the 6.3mm stereo jack there would be hazardous voltage accessible on the plug which could lead in the worst case to a serious electrical incident. in addition the current specification in the instruction for use (ifu) has an incorrect labelling with regard to the specified voltage for the alarm connectors. the translated ifu's and the "online help" of the instruments also have an incorrect labelling with regard to the specified voltage of the alarm connectors.

Device

ASP6025 TISSUE PROCESSOR
  • Modelo / Serial
    Model Catalog: ASP6025 (Lot serial: 314); Model Catalog: ASP6025 (Lot serial: 712); Model Catalog: ASP6025 (Lot serial: 778); Model Catalog: ASP6025 (Lot serial: 594); Model Catalog: ASP6025 (Lot serial: 538); Model Catalog: ASP6025 (Lot serial: 448); Model Catalog: ASP6025 (Lot serial: 316)
  • Descripción del producto
    Leica ASP6025 Tissue Processor
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH