Recall Z-1437-2013 ยท BZD Ventilator, Non-Continuous (Respirator)
Fisher & Paykel Healthcare, Ltd.
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 intende
| Date | May 30, 2013 (initiated Apr 22, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Fisher & Paykel Healthcare Limited, sent a "Medical Device Recall" letter dated April 22, 2013 to all their customers who purchased the Fisher & Paykel Healthcare ICON CPAP Replacement. The recall letter described the product, notified the customers of the problem identified and the actions to be taken. Customers are instructed to locate and verify if any of the affected products are in stock; check the part and lot numbers of your device; complete and return the enclosed Product Recall Response form, even if you have not received or distributed any affected products via Email: FA- |
| Quantity | 1,407 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K094040 | F&P ICON SERIES CPAP Fisher & Paykel Healthcare, Ltd., Apr 27, 2010 |