Events

Retiro De Equipo (Recall) de INTEGRA LED HEADLIGHT BATTERY CHARGER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INTEGRA CANADA ULC..

¿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
    112941
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-06
  • 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
    Integra lifesciences has identified through an investigation of complaints that some lot numbers of the integra led single bay battery charger (catalogue no. 90523) may prematurely fail and will not charge the integra led battery as intended. there have been no reports of an injury or other adverse patient consequences associated with the complaints. customers may have received an affected 90523 directly or had it provided with one of the following: led headlight systems (catalogue no. 90520us) or battery kits (catalogue no. 90530us).

Device

INTEGRA LED HEADLIGHT BATTERY CHARGER
  • Modelo / Serial
    Model Catalog: 95023 (Lot serial: > 10 numbers contact mfg.)
  • Descripción del producto
    INTEGRA LED BATTERY CHARGER SINGLE BAY
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.