Events

Retiro De Equipo (Recall) de Device Recall System O2 Portable Oxygen Delivery System (PODS).

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por System 02 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
    26198
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0929-03
  • Fecha de inicio del evento
    2003-05-01
  • Fecha de publicación del evento
    2003-06-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27245
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Generator, Oxygen, Portable - Product Code CAW
  • Causa
    System o2 oxygen flow rate found to be inadequate and rejuvo2 home oxygen bar contains 'adulterated labeling.'.
  • Acción
    Distributors were contacted by telephone with follow up letter sent via registered mail on 5/1/2002. System O2 has volunteered to handle mailings to end users and sub-distributors, and is also establishing a URL to warehouse recall information and forms. All Distributors, sub distributors, retailers and end users will be logged in a data base as Master Distributors forward that information. Results and effectiveness data will be logged in data base for tracking purposes.

Device

Device Recall System O2 Portable Oxygen Delivery System (PODS).
  • Modelo / Serial
    All units are under recall.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Units were sent to 2 direct distributors located in GA.
  • Descripción del producto
    System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.
  • Manufacturer
    System 02 Inc

Manufacturer

System 02 Inc
  • Dirección del fabricante
    System 02 Inc, 1090 Upper Hembree Rd, Roswell GA 300761140
  • Source
    USFDA