Z-1437-2013 Class II Terminated
FDA device recall Z-1437-2013 was initiated by Fisher & Paykel Healthcare, Ltd. on April 22, 2013 and is designated Class II. Reason for recall: 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 res… The recall status is terminated (terminated October 18, 2013). Affected quantity: 1,407 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- April 22, 2013
- Termination Date
- October 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,407 units
Product 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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Code Information
Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.