Reported Jun 5, 2013 · Terminated
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT,…
Fisher & Paykel Healthcare, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fisher & Paykel Healthcare, Ltd. · 15 Marcel Place · North Shore City, N/A · N/A
Is this the product you have?
- Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure)
- ModelsICON
- AutoICONAAN, ICONAAN-HT, ICONAAJ
- ICON NovoICONNAN, ICONNAN-HT, ICONNAJ
- ICON PremoICONPBN, 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
- Lot codes and dates
- Lot 121210
December 10th2012
- Lot 121221
December 21st2012
- Lot 121210
- Amount recalled
- 1,407 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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