Philips Respironics, Inc. recalls BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing mor…

Recall date

May 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2036-2025

FDA classification

Class I

Brand / firm

Philips Respironics, Inc.

Sold / distributed

Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR),…

Why it was recalled

This device does not indicate for use in patients with respiratory failure.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.