Events

Retiro De Equipo (Recall) de FRIGITRONICS CRYO-PLUS CRYOSURGERY SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOPERSURGICAL 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
    70706
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-26
  • 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
    Coopersurgical is advising all frigitronics cryo-plus cryosugery system users that there are questions regarding the validity of the current high level disinfection procedure for the shaft of the system's hand piece. this notification does not include any cryosurgical tips which currently have a validated high level disinfection procedure. therefore coopersurgical is advising all customers of record to practice all necessary diligence when using the device.

Device

FRIGITRONICS CRYO-PLUS CRYOSURGERY SYSTEM
  • Modelo / Serial
    Model Catalog: 2400 (Lot serial: All lots); Model Catalog: 2401 (Lot serial: All lots); Model Catalog: 2402 (Lot serial: All lots); Model Catalog: 50502 (Lot serial: All lots); Model Catalog: 50501 (Lot serial: All lots)
  • Descripción del producto
    Frigitronics Cryo-Plus Cryosurgery System
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.