FDA Device recall Z-1437-2013
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure)
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure) by Fisher And Paykel Healthcare, citing 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 inopera….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1437-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-22 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fisher And Paykel Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1437-2013%22
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