Events

Rappel de Fisher & Paykel Healthcare ICON CPAP

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Fisher & Paykel Healthcare, Ltd..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49033
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1437-2013
  • Date de mise en oeuvre de l'événement
    2013-04-22
  • Date de publication de l'événement
    2013-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-10-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72581
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
  • Source
    USFDA