Class 2 Device Recall Fisher & Paykel Healthcare ICON CPAP

• Date Initiated by Firm: April 22, 2013
• Date Posted: May 30, 2013
• Recall Status: Terminated on October 18, 2013
• Recall Number: Z-1437-2013
• Recall Event ID: 49033
• 510(K)Number: K094040
• Product Classification: Ventilator, non-continuous (respirator) - Product Code BZD
• Product: 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.
• Code Information: Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
• Recalling Firm/ Manufacturer: Fisher & Paykel Healthcare, Ltd.; 15 Marcel Place; East Tamaki; North Shore City New Zealand
• For Additional Information Contact: Raymond Yan; 949-4534000 Ext. 1423
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 1,407 units
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BZD and Original Applicant = FISHER & PAYKEL HEALTHCARE, LTD.