Events

Retiro De Equipo (Recall) de ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ROHO 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
    77328
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-22
  • 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 problem was discovered internally with a supplied component for the affected products. when a smart check by roho is used to perform a smart setup with one of the affected cushions the nonconforming part may adversely affect the setup process resulting in an improper cushion setup.

Device

ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY
  • Modelo / Serial
    Model Catalog: 1 R91 OM-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R91 OM-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R89M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R89M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R88M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R88M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R81 OM-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R78M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R78M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R77M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R77M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CH-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CA-SR (Lot serial: S/N:
  • Descripción del producto
    ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY;ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY
  • Manufacturer
    ROHO INC.

Manufacturer

ROHO INC.
  • Dirección del fabricante
    BELLEVILLE
  • Empresa matriz del fabricante (2017)
    Investor AB
  • Source
    HC