Philips Respironics, Inc.: Device Recall
Recall #Z-2035-2025 · 05/09/2025
Recall Details
- Recall Number
- Z-2035-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Philips Respironics, Inc.
- Status
- Ongoing
- Date Initiated
- 05/09/2025
- Location
- Murrysville, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,958 units
Reason for Recall
This device does not indicate for use in patients with respiratory failure.
Product Description
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Distribution Pattern
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).
Other Recalls by Philips Respironics, Inc.
- Class II: Risk 10/07/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 06/30/2025
- Class I: Dangerous 05/09/2025