Philips Updates Guidance for Recalled BiPAP Machines After Injury and Death Reports

Philips has revised usage instructions for its A30, A40, and V30 Auto BiPAP machines following a recall tied to an alarm malfunction that can interrupt or stop therapy. The FDA now links the issue to 13 injuries and eight deaths, up from earlier reports. The affected devices, nearly 90,000 worldwide (nine in the U.S.), treat obstructive sleep apnea and respiratory insufficiency.

The alarm defect can cause intermittent reboots or shutdowns, risking insufficient ventilation, low oxygen, high carbon dioxide, respiratory failure, or death. Updated instructions advise patients unable to tolerate therapy interruptions to transition to alternative ventilation and contact their equipment provider for a replacement.

This is the latest in a series of recalls and regulatory actions involving Philips’ Respironics division, including a 2021 foam degradation recall and a consent decree barring U.S. sales until FDA requirements are met. Philips has already paid about €1 billion in U.S. settlements linked to earlier recalls.

11-08-2025