Events

Retiro De Equipo (Recall) de Device Recall HomeFill Oxygen Compressor IOH200 Homefill

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 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
    57629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1423-2011
  • Fecha de inicio del evento
    2011-01-11
  • Fecha de publicación del evento
    2011-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96888
  • 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
    Invacare corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. it also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor failure/shutdown or to cause the motor.
  • Acción
    The firm, INVACARE Corp., sent an "URGENT PRODUCT RECALL: IOH 200 Homefill Recall" letter dated January 10, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to "immediately examine their inventory and quarantine product subject to recall. In addition, if they may have further distributed this product, please identify their customers and notify them at once of this product recall." The customers were also instructed to complete and return an enclosed response form. Note: All product is to be return to the recalling firm. If you have any questions, contact the Manager, Regulatory Affairs at (440) 329-6356.

Device

Device Recall HomeFill Oxygen Compressor IOH200 Homefill
  • Modelo / Serial
    The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: FL, GA, KY, LA, MO, NC, NE, NJ and SC.
  • Descripción del producto
    HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. || The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Dirección del fabricante
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA