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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).
- Patients
Voluntary Recall Information ... Registration for affected...
- Business customers
Voluntary Recall Information ... Registration for affected...
- Clinicians
Voluntary Recall Information. Philips Respironics Sleep and...
- News and Updates
Voluntary Recall Information Philips Respironics Sleep and...
- Contact and support
Contact and support options for patients impacted by the...
- Ozone Cleaner Information
“Follow the CPAP manufacturer’s instructions and recommended...
- Starts Repair and Replacement
Philips has received authorization from the US Food and Drug...
- Voluntary Recall Information
In June 2021, after discovering a potential health risk...
- Patients
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).
The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
Voluntary Recall Information. Philips Respironics Sleep and Respiratory Care devices. Registration for affected CPAP and BiPAP devices in the US and Canada ends at 11:59 p.m. EST, December 31, 2024. Register now. Important information for clinicians. Sleep Therapy information.
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.
16 maj 2023 · The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices indicate that potential patient exposure to foam particulates and volatile organic compounds (VOCs) from the polyester-based polyurethane (PE-PUR) foam within the breathing gas pathway of these devices is unlikely to result in an appreciable harm to health in ...