Events

Retiro De Equipo (Recall) de PENTAX VB-2000 VIDEO BRONCHOSCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PENTAX 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
    98635
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-10
  • 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
    Pentax medical has become aware that some customers may own legacy endoscopes where the screw connecting the suction arm to the control body could loosen with time. a loose suction arm may result in inadequate suctioning due to leakage of air. there is also the potential for organic debris to accumulate in the space between the suction nipple and control body. in some cases these events could cause cross-contamination between patients.

Device

PENTAX VB-2000 VIDEO BRONCHOSCOPE
  • Modelo / Serial
    Model Catalog: EB-1970TK (Lot serial: G111020); Model Catalog: EB-117OK (Lot serial: G110123); Model Catalog: EB-1970K (Lot serial: G110123); Model Catalog: EB-1970TK (Lot serial: G110123); Model Catalog: EB-117OK (Lot serial: G110458); Model Catalog: EB-1570K (Lot serial: G110458); Model Catalog: EB-1970K (Lot serial: G110458); Model Catalog: EB-1970TK (Lot serial: G110458); Model Catalog: EB-117OK (Lot serial: G110907); Model Catalog: EB-1570K (Lot serial: G110907); Model Catalog: EB-1970K (Lot serial: G110907); Model Catalog: EB-1970TK (Lot serial: G110907); Model Catalog: EB-117OK (Lot serial: G110589); Model Catalog: EB-1570K (Lot serial: G110589); Model Catalog: EB-1970K (Lot serial: G110589); Model Catalog: EB-1970TK (Lot serial: G110589); Model Catalog: EB-117OK (Lot serial: G110017); Model Catalog: EB-1570K (Lot serial: G110017); Model Catalog: EB-1970K (Lot serial: G110017); Model Catalog: EB-1970TK (Lot serial: G110017); Model Catalog: EB-117OK (Lot serial: G110029); Model Catalog: EB-1570K (Lot s
  • Descripción del producto
    PENTAX VB-2000 VIDEO BRONCHOSCOPE;E.N.T. SCOPE;SLIM CYSTOSCOPE SET
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

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