Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICON

FDA device recall Z-1437-2013 · posted 2013-05-30 · Terminated

Recall details

Recalling firm

Fisher & Paykel Healthcare, Ltd.

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.

Action taken

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-2013-001@fphcare.com; 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 FA-2013-001@fphcare.com 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 FA-2013-001@fphcare.com or directly at (800) 792-3912 ext. 1426.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BZD

Quantity affected

1,407 units

Distribution

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

Date initiated

2013-04-22

Date posted

2013-05-30

Date terminated

2013-10-18

Location

North Shore City, East Tamaki, New Zealand

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