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).

2024年11月20日 · 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...

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.

2023年5月16日 · 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).

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

2023年9月27日 · 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).

Philips has updated the US recall notification to align with the FDA’s recommendation in connection with these recalls and provide broader guidance on use. For patients using BiLevel PAP and CPAP devices, consult with your physician on a suitable treatment plan.

As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

2021年6月14日 · Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure...

2024年11月20日 · 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,...