FDAFDA · Food and drugs·Recall number Z-1437-2013
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.
Published June 5, 2013 · Recall initiated: April 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Distributor
- Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
- Lot
- Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- New Zealand
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