BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1437-2013 · Initiated April 22, 2013

    Recall

    Recall Number
    Z-1437-2013
    Event Number
    49033
    Firm
    Fisher & Paykel Healthcare, Ltd.
    FEI Number
    3002806988
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2013
    Posted
    May 30, 2013
    Terminated
    October 18, 2013
    Address
    15 Marcel Place East Tamaki, North Shore City 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.

    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.

    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: [email protected]; Fax: (949) 453-4001; or Post: Fisher & Paykel Healthcare,15365 Barranca Parkway, Irvine, CA 92618; transfer this notice immediately to all those who need to be aware and if affected product has been distributed to any other organizations or distributors, notify them regarding the recall within 10 business days upon receipt of this letter; prepare any products to be returned to Fisher & Paykel Healthcare and contact the field action coordinator via email at [email protected] or directly at 1-800-792-3912 ext. 1426 to arrange for a return shipping label to be sent to you. If you have any questions related to this recall, contact the field action coordinator via email at [email protected] or directly at (800) 792-3912 ext. 1426.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.

    Quantity

    1,407 units