FDA-Device2025-07-09Class I
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Hazard
This device does not indicate for use in patients with respiratory failure.
Sold states
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).
Affected count
6 units in US 67534 OUS
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2037-2025More Philips Respironics, Inc. recalls
- FDA-Device2026-04-08Philips Respironics Trilogy Evo O2 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo Universal ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy EV300 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-01Philips Respironics Trilogy Evo ventilator recalled for inaccurate breath volume delivery with certain nebulizers
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