Medical Device Recall Information - Philips Respironics Sleep and ...
In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).
Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
Nov 20, 2024 · 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...
Contact and support for Philips Respironics voluntary recall
Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam
Voluntary Recall Information - Philips
Jun 29, 2023 · If you registered a first-generation DreamStation CPAP, BiPAP Pro or Auto BiPAP device, we may need your device prescription and are unable to ship your replacement device until it’s provided.
FDA Activities Related to Recalled Philips Devices
Nov 20, 2024 · On June 30, 2021, the FDA alerted people who use certain Philips Respironics (Philips) ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines,...
Problems Reported with Recalled Philips Ventilators, BiPAP …
In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP...
Explained: 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.
Recalled Philips sleep apnea machines linked to 500 deaths: FDA - USA TODAY
Feb 2, 2024 · The U.S. Food and Drug Administration (FDA) has issued an update to a recall affecting millions of Philips sleep apnea machines, saying that they may be linked to at least 561 reported deaths.
Sleep and respiratory care update | Philips
At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
News & updates | Philips
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).
- Some results have been removed