FDA Devices Critical Class I Ongoing

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

Reported: July 9, 2025 Initiated: May 9, 2025 #Z-2035-2025

Product Description

Reason for Recall

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

Details

Recalling Firm: Philips Respironics, Inc.
Units Affected: 5,958 units
Distribution: 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), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
Location: Murrysville, PA

Frequently Asked Questions

What product was recalled? ▼

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.. Recalled by Philips Respironics, Inc.. Units affected: 5,958 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 9, 2025. Severity: Critical. Recall number: Z-2035-2025.