Fisher & Paykel Recalls ICON CPAP Units Due to Power Issue
Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is the lack of treatment for a medical condition, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Fisher & Paykel Healthcare is recalling 1,407 units of the ICON CPAP (continuous positive airway pressure) device. The affected models include ICON Auto (ICONAAN, ICONAAN-HT, ICONAAJ), ICON Novo (ICONNAN, ICONNAN-HT, ICONNAJ), and ICON Premo (ICONPBN, ICONPBN-HT, ICONPBN-HTC). The devices were distributed worldwide, including the United States, Canada, Japan, and Taiwan.
The recall is due to a potential power issue that could cause the units to become inoperable. If a unit stops working, patients will not receive treatment for their obstructive sleep apnea symptoms until a replacement unit is obtained. The affected units are from Lot 121210 (December 10, 2012) and Lot 121221 (December 21, 2012).
The ICON CPAP unit is intended for use on adult patients in the home or sleep laboratory to treat obstructive sleep apnea. It is not intended to be used as a life-supporting device. Consumers should contact Fisher & Paykel Healthcare for instructions on how to obtain a replacement unit.
The recalled product
- 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 t
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Category
- Medical Device — CPAP
- Affected units
- 1,407
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 121210: December 10th
- 2012. Lot 121221: December 21st
- 2012.
Distribution
Distributed nationwide across the United States.
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