Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1437-2013 — 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 Obst

U.S. FDA — Device Enforcement · New Zealand · 2013-04-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1437-2013
Date of alert: 2013-04-22
Country / jurisdiction: New Zealand
Risk level: Class II
Risk type: recall
Brand: Fisher & Paykel Healthcare, Ltd.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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