Phillips Respironics has updated its usage instructions for three of its BiPAP ventilator models after reports of therapy interruptions and device failures that could result in serious injury or death.
The recalled devices, BiPAP A30, A40 and V30 Auto, may reboot unexpectedly, stop therapy or enter a complete inoperative state which can trigger alarms incorrectly, according to an Aug. 4 news release from the FDA.
The devices are used to support patients with obstructive sleep apnea and respiratory insufficiency in both home and clinical settings. While the recall does not involve removing devices from use or sale, Phillips issued an urgent medical device recall notice March 19, 2024, advising patients and caregivers to switch to alternate ventilation if needed.
Thirteen injuries and eight deaths have been reported.
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