Device 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.
Z-1437-2013
Product summary
- Event
- Event 49033
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,407 units
- Official record key
device-enforcement:Z-1437-2013
Official wording
Reason: 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.
Code information: Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Derived failure modes
-
Unknown
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.