Fisher & Paykel Healthcare ICON CPAP — Class II medical device recall Z-1437-2013
Terminated recall by Fisher & Paykel Healthcare, Ltd., reported 2013-06-05, distributed nationwide. Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on cert
| Recall number | Z-1437-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., North Shore City, N/A, New Zealand |
| Recall initiated | 2013-04-22 |
| Classified | 2013-05-30 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, TW |
| Quantity | 1,407 units |
| Lot numbers | 121210, 121221 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1437-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.