Recall Z-2035-2025— Philips Respironics, Inc.

Name: FDA recall Z-2035-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-09

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2025-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.. Reason: This device does not indicate for use in patients with respiratory failure..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-05-09
Firm location: Murrysville, PA, United States

Product description

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.