Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICO...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1437-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1437-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1437-2013.
Fisher & Paykel Healthcare, Ltd.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Fisher & Paykel Healthcare, Ltd. Recall FAQ
Fisher & Paykel Healthcare, Ltd. is the subject of a respiratory devices safety report: Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICO.... The notice was published on April 22, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 1,407 units are potentially affected.