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Fisher & Paykel Healthcare

FISHER & PAYKEL HEALTHCARE LIMITED · Model 900PT460D · UDI-DI 09420012470010

QAV Prescription
3
510(k) clearances
38
Adverse events (3 deaths)
1
Recalls
6
Facilities

Description

HPO Dual-input Manifold (DISS) Airvo 3

Recalls

DateFirmReason
2024-08-07Fisher & Paykel Healthcare, Ltd.Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happe

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.