CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
Icon CPAP (continuous positive airway pressure) recalled
Fisher & Paykel Healthcare is recalling Icon CPAP (continuous positive airway pressure), distributed nationwide in the US. The recall was initiated on 22 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1437-2013
- FDA event ID
- 49033
- Recalling firm
- Fisher & Paykel Healthcare, North Shore City, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2013
- FDA classified
- 30 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 22 Apr 2013 | Recall initiated by company | |
| 30 May 2013 | Classified by FDA | +38 days |
| 5 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
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