Events

Retiro De Equipo (Recall) de Fisher & Paykel Healthcare ICON CPAP

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 Fisher & Paykel Healthcare, 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
    49033
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1437-2013
  • Fecha de inicio del evento
    2013-04-22
  • Fecha de publicación del evento
    2013-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72581
  • 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
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Causa
    Fisher and paykel healthcare is recalling the icon cpap units because there is a potential power issue on certain icon cpap. these icon cpap units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
  • Acción
    The firm, Fisher & Paykel Healthcare Limited, sent a "Medical Device Recall" letter dated April 22, 2013 to all their customers who purchased the Fisher & Paykel Healthcare ICON CPAP Replacement. The recall letter described the product, notified the customers of the problem identified and the actions to be taken. Customers are instructed to locate and verify if any of the affected products are in stock; check the part and lot numbers of your device; complete and return the enclosed Product Recall Response form, even if you have not received or distributed any affected products via Email: FA-2013-001@fphcare.com; Fax: (949) 453-4001; or Post: Fisher & Paykel Healthcare,15365 Barranca Parkway, Irvine, CA 92618; transfer this notice immediately to all those who need to be aware and if affected product has been distributed to any other organizations or distributors, notify them regarding the recall within 10 business days upon receipt of this letter; prepare any products to be returned to Fisher & Paykel Healthcare and contact the field action coordinator via email at FA-2013-001@fphcare.com or directly at 1-800-792-3912 ext. 1426 to arrange for a return shipping label to be sent to you. If you have any questions related to this recall, contact the field action coordinator via email at FA-2013-001@fphcare.com or directly at (800) 792-3912 ext. 1426.

Device

Fisher & Paykel Healthcare ICON CPAP
  • Modelo / Serial
    Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
  • Descripción del producto
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). || Models: || ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. || ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. || ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. || The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
  • Manufacturer
    Fisher & Paykel Healthcare, Ltd.

Manufacturer

Fisher & Paykel Healthcare, Ltd.
  • Dirección del fabricante
    Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
  • Source
    USFDA