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.
Enforcement
- Recall Number
- Z-1437-2013
- Event ID
- 49033
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fisher & Paykel Healthcare, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 5, 2013
- Initiation Date
- April 22, 2013
- Classification Date
- May 30, 2013
- Termination Date
- October 18, 2013
- Address
- 15 Marcel Place, East Tamaki, North Shore City, N/A, N/A, New Zealand
Description
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.
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.
Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
1,407 units