Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for ped…
Reason for recall
This device does not indicate for use in patients with respiratory failure.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Lot / code information
- Part / Item #
- 1111178
- UDI
- 0060959049635
- Serial #
N2068642229E4, N206864244CD2, N206864255D5B, N206864277E49, N2068642886BE, N206864299737 — +2164 moreShow all
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N21448244802A, N2144824591A3, N21448246A338, N21448247B2B1, …
Additional code information
, N23649815BF37, N23649844D006, N23649845C18F, N23649846F314, N23649847E29D, N236498481A6A, N236498490BE3, N236498508FFA, N236498519E73, N23649852ACE8, N23649853BD61, N23649854C9DE, N23649855D857, N23649856EACC, N23649857FB45, N23649859123B, N23649860A592, N23649861B41B, N236498628680, N236498639709, N23649864E3B6, N23649865F23F, N23649866C0A4, N23649867D12D, N2364986829DA, N236498693853, N23649870BC4A, N23649871ADC3, N236498738ED1, N23649874FA6E, N23649875EBE7, N23649876D97C, N23649877C8F5, N236498783002, N23649879218B, N236498803F82, N236498812E0B, N236498821C90, N236498830D19, N2364988479A6, N23649885682F, N236498865AB4, N236498874B3D, N23649888B3CA, N23649889A243, N23649890265A, N236498920548, N2364989314C1, N23899361D86B, N2389938415D6, N2356309026C3, N23563150D5BF, N2364989137D3, N23563100AB07, N23649820C2F2, N23649826A7C4, N236498349D0E, N2364985803B2, N238993597E4B, N238993785C72, N23563121893E, N23649830DB2A, N236498729F58, N235630729FC1, N23899348761A, N239001181136, 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N2508138482DF, N251462142B21, N24319198C3C7, N246286985A32, N246891955DC1, N246891977ED3, N2468919997AD, N246892003210 …
What the firm is doing
Philips sent an "URGENT Medical Device Recall Notice", for All BiPAP A30 and BiPAP A40 devices, to consignees via mail 5/9/2025. Note, the letter does not address BiPAP V30 devices. The Notice informs consignees that for patients who cannot tolerate interruption or loss of therapy an alternative ventilator is required. Philips Respironics recommends that physicians and healthcare professionals assess whether the patients under their care who are using affected devices are able to tolerate interruptions to therapy. For patients who can and cannot tolerate interruptions in therapy, Philips Respironics provides recommendations for the clinicians and patients to consider. Patients who cannot tolerate interruptions in therapy are directed to contact their physician to expedite transition to an alternative ventilator. If a Ventilator Inoperative alarm occurs and an alternative is not available, follow Appendix A3 on how to perform a hard reboot. Consignees with any questions are to call 1-800-345-6443, prompts 4/5 or email respironics.clinical@philips.com. An additional communication was sent to consignees on 9/12/25 with further guidance for users.
DistributionShow detailsHide
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).
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2035-2025
- FDA device classification · MNSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5895The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips Respironics, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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