Recall Z-1437-2013— Fisher & Paykel Healthcare, Ltd.

Name: FDA recall Z-1437-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-22

Class II · Terminated

Class II FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2013-04-22, terminated 2013-10-18. It names one FDA 510(k) clearance: K094040. 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.. Reason: 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..

Recalling firm: Fisher & Paykel Healthcare, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2013-04-22
Terminated: 2013-10-18
Firm location: North Shore City, N/A, New Zealand

510(k) clearances named in this recall

1 on FDA's record

K094040 — F&P ICON SERIES CPAPFisher & Paykel Healthcare, Ltd.·cleared 2010-04-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.