Fisher & Paykel Healthcare, Ltd.: Medical Device Recall in 2013 - (Recall #: Z-1437-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 22, 2013

Date Posted: June 5, 2013

Recall Number: Z-1437-2013

Event ID: 49033

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.

Status: Terminated

Product Quantity: 1,407 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated