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  1. www.fda.gov › medical-devices › respiratory-devicesRecalled Philips Ventilators, BiPAP Machines, and CPAP Machines

    5 Οκτ 2023 · In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway...

  2. www.fda.gov › medical-devices › medical-device-recallsPhilips Respironics Recalls Certain BiPAP Machines for Plastic...

    6 Δεκ 2022 · Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may...

  3. www.fda.gov › medical-devices › safety-communicationsCertain Philips BiPAP Machines Recalled Due to a Plastic Issue

    On August 26, 2022, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter.

  4. www.philips.com › update › documentsURGENT: Medical Device Recall - Philips

    URGENT: Medical Device Recall Philips Respironics CPAP and Bi-Level PAP Devices Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission Dear Device Customer, Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the

  5. www.usa.philips.com › healthcare › eMedical Device Recall Information - Philips Respironics Sleep and...

    Voluntary Recall Information. Philips Respironics Sleep and Respiratory Care devices. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

  6. www.philips.com › a-w › aboutExplained: The voluntary Philips Respironics sleep and

    In June 2021, Philips initiated a voluntary recall notification / field safety notice for certain CPAP and BiPAP sleep therapy devices and mechanical ventilators to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices.

  7. www.results.philips.com › publications › q423Philips Respironics recall notification/field safety notice*...

    29 Ιαν 2024 · Based on the latest test results for the CPAP/BiPAP sleep therapy devices, is Philips Respironics saying they are safe for patients to use? The extensive data and results now available for the first-generation DreamStation, System One and DreamStation Go devices indicate that the use of these devices is unlikely to result in

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