Events

Recall of Fisher & Paykel Healthcare ICON CPAP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher & Paykel Healthcare, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49033
  • Event Risk Class
    Class 2
  • Event Number
    Z-1437-2013
  • Event Initiated Date
    2013-04-22
  • Event Date Posted
    2013-05-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72581
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Reason
    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
  • Model / Serial
    Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
  • Product Description
    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.
  • Manufacturer Address
    Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
  • Source
    USFDA