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3 cze 2024 · Amid concerns of health problems associated with the sound abatement foam used in their continuous positive airway pressure (CPAP) devices, Philips Respironics issued a voluntary recall on 5.5 million ventilators, BiPAP machines, and …
18 sty 2024 · Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled ResMed masks. ResMed is making replacement masks without magnets available to mask providers.
12 sty 2024 · ResMed Ltd. is recalling all their Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible magnetic interference with certain medical devices.
31 sty 2023 · Philips Respironics (Philips) is recalling certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks due to a serious safety...
In 2021, Philips Respironics determined from user reports and initial testing that there were possible risks to users related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and ventilator devices. Following the issuance of the recall
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).
20 wrz 2024 · On January 12, 2024, the U.S. Food and Drug Administration (FDA) classified a recall on certain ResMed CPAP masks as Class I, their most serious category. ResMed originally issued the recall on November 20, 2023.
