Events

Retiro De Equipo (Recall) de CARROLL CS SERIES CS7 BED

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

¿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
    53838
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-12-18
  • 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
    A potential defect involving the invacare carroll cs7 bed model ihcs7hlock-c. the potential defect will not allow assembly of 36" wide cs assist rails 36" wide cs assist bars & 68" partial length rail onto the bed. the mounting bracket on the bed was incorrectly welded by 180 degrees which does not allow for the rail accessories to be installed onto the bed. the defective mounting rail brackets are located on the frame of the bed on both sides. the bottom square hole of the bracket does not align with the rail or rail accessories.

Device

CARROLL CS SERIES CS7 BED
  • Modelo / Serial
    Model Catalog: IHCS7HLOCK-C (Lot serial: >100 NUMBERS CONTACT MFG)
  • Descripción del producto
    INVACARE CARROLL CS7 BED
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION