Product Detail

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.

Recall Number Z-1437-2013

Classification Class II

Code Info Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.

Product Distributed Qty 1,407 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.

Event Detail

Event Id 49033

Product Type Devices

Status Ongoing

Recalling Firm
Fisher & Paykel Healthcare, Ltd.
City North Shore City

Country NZ

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-22

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.