Events

Retiro De Equipo (Recall) de RAINBOW REUSABLE SENSORS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHYSIO-CONTROL CANADA SALES LTD.

¿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
    46956
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-21
  • 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
    Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behavior will depend on the firmware version of the technology board in the device. spco measurements when displayed could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5% on average.

Device

RAINBOW REUSABLE SENSORS
  • Modelo / Serial
    Model Catalog: 2696 (Lot serial: BOX LOT 15HA6); Model Catalog: 2696 (Lot serial: BOX LOT # 15JA8); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15H754); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15G760); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15J824); Model Catalog: 2696 (Lot serial: Sensor Ref#/LOT# 24087-A15H754); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15J726)
  • Descripción del producto
    Rainbow Reusable Sensors
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC