FDA Devices Critical Class I Ongoing

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

Reported: July 9, 2025 Initiated: May 9, 2025 #Z-2037-2025

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: 6 units in US 67534 OUS
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 A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS. Recalled by Philips Respironics, Inc.. Units affected: 6 units in US 67534 OUS.

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-2037-2025.