Events

Retiro De Equipo (Recall) de LIFEDOP 250 SYSTEM - PROBES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES.

¿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
    17960
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-10-06
  • 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 coopersurgical 2 mhz waterproof ob probe is for obstetrical use in the labor and delivery department for late term obstetrical examination associated with larger women. the product detects fetal heart beats as an aid for determining fetal viability. coopersurgical quality assurance program identified that the 2mhz is incorrectly labeled with the 3 mhz probe label on september 19 2017. the event was discovered internally during product complaint investigation.

Device

LIFEDOP 250 SYSTEM - PROBES

Manufacturer

COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES