Events

Retiro De Equipo (Recall) de COMFORTLINE CHAIR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH 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
    93782
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-25
  • 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 instructions for use of the therapy chair <>serial number starting from 06c06-018 has been amended to included the following: during installation of the therapy chair the installing staff has to make sure that the seat of the chair is installed correctly and according to the instruction for use. if the seat is not locked properly it might slide unintentionally.

Device

COMFORTLINE CHAIR
  • Modelo / Serial
    Model Catalog: 110014 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17039 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 110015 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 113789 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 114665 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: NVM-10336 (Lot serial: 06C06-018); Model Catalog: LOC-17119 (Lot serial: 06C06-018); Model Catalog: LOC-17097 (Lot serial: 06C06-018); Model Catalog: LOC-17070 (Lot serial: 06C06-018); Model Catalog: LOC-17039 (Lot serial: 06C06-018); Model Catalog: 114665 (Lot serial: 06C06-018); Model Catalog: 113789 (Lot serial: 06C06-018); Model Catalog: 110015 (Lot serial: 06C06-018); Model Catalog: 109434 (Lot serial: 06C06-018); Model Catalog: 110014 (Lot serial: 06C06-018); Model Catalog: NVM-10336 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17119 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17097 (Lot serial: SERIAL NUMBERS STARTING FROM)
  • Descripción del producto
    BIONIC COMFORTLINE CHAIR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC