BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2037-2025 · Initiated May 9, 2025

    Recall

    Recall Number
    Z-2037-2025
    Event Number
    96948
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    MNT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 9, 2025
    Posted
    July 2, 2025
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

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

    Reason

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

    Action

    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 [email protected]. An additional communication was sent to consignees on 9/12/25 with further guidance for users.

    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).

    Quantity

    6 units in US 67534 OUS