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.
FDA Recall Z-1437-2013 · Posted 2013-05-30
Recalling FirmFisher & Paykel Healthcare, Ltd.
Recall StatusTerminated
Product CodeBZD
Date Initiated2013-04-22
Date Terminated2013-10-18
Product Quantity1,407 units
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.
Firm 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: [email protected]; 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 [email protected] 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 [email protected] or directly at (800) 792-3912 ext. 1426.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.