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Medical Device Recall Information - Philips Respironics Sleep and ...
Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients.
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...
Philips Respironics Recalls Certain Reworked DreamStation …
Certain Philips Respironics DreamStation CPAP and BiPAP Machines are recalled because they may not deliver the right correct amount of breathing support.
Voluntary Recall Information - Philips
Dec 31, 2024 · Philips Respironics will no longer accept new registrations for affected CPAP and BiPAP devices in the US after December 31, 2024. To receive a replacement device or financial payment, please be sure to register your device prior to the end of the year.
Voluntary Recall Information - Philips
Jun 29, 2023 · Depending on your specific situation, you may be eligible to select an Auto-adjusting CPAP replacement device. If you registered a DreamStation Go, there are two options for remediation that are now available to you. You must select one of the following two options below in the Patient Portal.
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.
Philips provides update on recall notification - News | Philips
Jun 14, 2021 · Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue. To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices, that are available in the US and selected countries in Europe.
announcement of the recall notification/field safety notice* in June 2021, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. At the
Philips Respironics Sleep and Respiratory Care devices | Philips
Sep 27, 2023 · 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).
Carefully Monitor Philips DreamStation 2 CPAP Machines for …
Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency...
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