In addition, patients who are on the go either with travel for work or on vacation can carry everything they need for successful Sleep Apnea therapy. By combining multiple treatment approaches in one unit, this CPAP device is a great mid-priced solution for CPAP therapy. The ICON Auto CPAP Machine by Fisher & Paykel has simplified Sleep Apnea therapy.
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Should you upgrade to one of the tech-focused machines or can you treat your Sleep Apnea effectively using the ICON Auto CPAP Machine? Consider this unbiased ICON Auto CPAP Machine Review to help you make the smartest decision for your treatment. Yet the influx of new automated continuous positive airway pressure machines like the ResMed AirSense 10 AutoSet, which features data tracking, has given customers pause.
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Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = BZD and Original Applicant = FISHER & PAYKEL HEALTHCARE, LTD.The Fisher & Paykel ICON Auto CPAP Machine is one of the more well-balanced Sleep Apnea treatment devices. 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. Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.ġ A record in this database is created when a firm initiates a correction or removal action. If you have any questions related to this recall, contact the field action coordinator via email at or directly at (800) 792-3912 ext. 1426 to arrange for a return shipping label to be sent to you. 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: 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 or directly at 1-80 ext. The recall letter described the product, notified the customers of the problem identified and the actions to be taken. The firm, Fisher & Paykel Healthcare Limited, sent a "Medical Device Recall" letter dated Apto all their customers who purchased the Fisher & Paykel Healthcare ICON CPAP Replacement. 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. Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.įisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. The device is not intended to be used as a life supporting device.
The device is for use in the home or sleep laboratory. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. Ventilator, non-continuous (respirator) - Product Code BZDįisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure).
Class 2 Device Recall Fisher & Paykel Healthcare ICON CPAP
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