Z-1437-2013Class II

Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN...

Name: Z-1437-2013 Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN...
Creator: Fisher & Paykel Healthcare, Ltd.
Published: 2013-04-22
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2013-04-22 / Terminated / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare, Ltd. began a recall of Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT... on 2013-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1437-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-22
Posted: 2013-05-30
Terminated: 2013-10-18
Recalling firm: Fisher & Paykel Healthcare, Inc.
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.
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
Root cause tag: manufacturing process
FDA root 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: [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.
Quantity in commerce: 1,407 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Product codes and lots: Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1437-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1437-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-30

Product code BZD

K094040Class IIF&p Icon Series CPAPFisher & Paykel Healthcare, Ltd. / cleared 2010-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)